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Communicable Disease Control

Immunization Program
Section VII Biological Products
December 2010
Page 1


TABLE OF CONTENTS

Diphtheria - Tetanus- Acellular Pertussis - Hepatitis B- Polio- Haemophilus Influenzae 1
Type b Adsorbed (DTaP- HB- IPV- Hib) (INFANRIX hexa)................................................ 1
INITIAL SERIES ...................................................................................................................... 1
Diphtheria -Tetanus - Acellular Pertussis-Polio-Haemophilus Influenzae Type b
Adsorbed (DTaP-IPV-Hib) (PEDIACEL) ............................................................................. 2
Diphtheria-Tetanus- Acellular Pertussis - Polio Adsorbed (DTaP-IPV) (QUADRACEL) 3
Haemophilus B Conjugate Vaccine (Act-HIB ) ................................................................. 4
Hepatitis A Vaccine: Indications........................................................................................... 5
Hepatitis A Vaccine (Inactivated Viral) (Havrix )............................................................... 6
Hepatitis A Vaccine (Inactivated Viral) (Vaqta )................................................................ 8
Hepatitis A Vaccine (Inactivated Viral) (Avaxim).............................................................. 9
Hepatitis A Vaccine (Inactivated Viral) (Avaxim Pediatric) ........................................... 10
Hepatitis B Immune Globulin (HBIg) (BayHep B ).......................................................... 11
Table 5: Hepatitis B Post-Exposure Prophylaxis .............................................................. 13
Hepatitis B Vaccine Pre-exposure Indications.................................................................. 14
Hepatitis B Vaccine for Students of Health Care Professions......................................... 15
Hepatitis B Vaccine (Engerix-B)....................................................................................... 16
Hepatitis B Vaccine Pre-Exposure (RecombivaxHB) (10 mcg/1.0 ml) .......................... 17
Hepatitis B Vaccine Options for 2010/2011 Grade 6 Series Completion....................... 18a
Hepatitis B Vaccine Post-Exposure Indications................................................................ 19
Hepatitis B Vaccine Post Exposure (RecombivaxHB) (10 mcg/1.0 ml) ........................ 20
Hepatitis B Vaccine Program for Chronic Kidney Disease Clients ................................. 21
Hepatitis A and B Vaccine Combined (Inactivated Viral) (Twinrix ) ............................. 22
Hepatitis A and B Vaccine Combined (Inactivated Viral) (Twinrix Junior) .................. 23
Human Papillomavirus Vaccine (GARDASIL) ................................................................. 24
Immune Globulin (Ig) (GamaSTAN S/D) .......................................................................... 26
Immune Globulin Preparations or Blood: Timing Intervals For Vaccines Containing Live
Measles, Mumps, Rubella, or Varicella Virus .................................................................... 29
Seasonal Trivalent Influenza Vaccine (Inactivated Split Virion or Subunit) ................... 31
Influenza Vaccine (Inactivated Split Virion) (FLUVIRAL) ............................................... 32
Influenza Vaccine (Inactivated Split Virion) (Thimerosal-reduced VAXIGRIP) ............ 34
Influenza Vaccine (Inactivated Subunit) (INFLUVAC).................................................... 35
Influenza Vaccine (Inactivated Subunit) (AGRIFLU) .................................................... 34a
Influenza Vaccine (Live, Attenuated) (FLUMIST) .......................................................... 34b
Influenza Vaccine (Inactivated Split Virion) (INTANZA) .............................................. 34c
Measles/Mumps/Rubella Vaccine (Live Attenuated Viral) MMRII & Priorix.............. 35
Meningococcal C Conjugate (MCC) Vaccine (Meningitec) ............................................ 37
Meningococcal C Conjugate (MCC) Vaccine (Neis Vac-C) ............................................ 39
Meningococcal Quadrivalent Conjugate Vaccine (Menactra) ....................................... 41
Meningococcal Quadrivalent Polysaccharide Vaccine (Menomune) ........................... 43
Pneumococcal Conjugate Vaccine (Prevnar

13) .............................................................. 44
Completing a Pneumococcal Conjugate Vaccine Series ................................................. 45
Pneumococcal Polysaccharide Vaccine (Pneumo 23) .................................................. 47
Pneumococcal Polysaccharide Vaccine (Pneumovax 23) ............................................ 49
Polio Vaccine (Inactivated) (Imovax Polio) (vero cell origin) ........................................ 51
Human Rabies Immune Globulin (RabIg) (HYPERRAB S/D) ........................................ 53
Communicable Disease Control
Immunization Program
Section VII Biological Products
December 2010
Page 2

Rabies Vaccine Pre-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated)
Imovax Rabies ................................................................................................................... 55
Rabies Vaccine Post-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated)
ImovaxRabies .................................................................................................................... 57
Rabies Vaccine Pre-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine]
(PCECV.................................................................................................................................. 59
Rabies Vaccine Post-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine
(PCECV)] ............................................................................................................................... 61
Rotavirus Vaccine (Pentavalent Human-bovine reassortant) (Oral live attenuated viral)
(RotaTeq).......................................................................................................................... 62a
Rotavirus Vaccine (Human rotavirus, live attenuated, oral vaccine) (Rotarix).......... 62c
Tetanus-Diphtheria (Td) Adsorbed..................................................................................... 63
Tetanus-Diphtheria-acellular Pertussis (Tdap) (ADACEL) ............................................ 64
Tetanus-Diphtheria-Inactivated Poliomyelitis Adsorbed (Td/IPV) ................................... 66
Tetanus Immune Globulin (TIg) (HYPERTETS/D)........................................................... 67
Tetanus Prophylaxis in Wound Management.................................................................... 69
Tuberculin Skin Test (Mantoux) Tubersol ...................................................................... 70
Typhoid Vaccine (Salmonella Capsular Polysaccharide) (Inactivated) (Typhim Vi) ... 72
Typhoid Vaccine (Live Oral Attenuated Ty21a) in capsule presentation (Vivotil)....... 73
Typhoid Vaccine (Salmonella Typhi Vi Capsular Polysaccharide)(Typherix) ............. 75
Varicella Zoster Immune Globulin (VariZIG) .................................................................. 76
Varicella Vaccine (live attenuated viral) Varivax III and Varilrix................................. 78
Varicella Zoster Vaccine (live attenuated viral) (ZOSTAVAX) ....................................... 81
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 1


Diphtheria - Tetanus- Acellular Pertussis - Hepatitis B- Polio- Haemophilus Influenzae
Type b Adsorbed (DTaP- HB- IPV- Hib) (INFANRIX hexa)
Supplier: GlaxoSmithKline Inc
INDICATIONS INITIAL SERIES
(1) Primary series for infants born on or after December 1, 2008
starting at 2 months of age
(2) Primary series for high risk infants who have received a
birth dose of HBIg and/or Hepatitis B vaccine


(3) Primary series for previously unimmunized infants and
children who are late starting immunization and can complete a
primary INFANRIX hexa series before 7 years of age
(1) & (2) Dose 1: 0.5ml IM
Dose 2: 0.5ml IM
Dose 3: 0.5ml IM
Give each dose 2 months
apart

(3) See Section II A 1.2
SCHEDULE B
REINFORCEMENTS
(1) & (2) Booster dose at 18 months of age: 0.5 ml IM of DTaP-IPV-Hib (PEDIACEL)

(3) Booster dose 6-12 months after dose 3:
0.5ml IM of DTaP-IPV-Hib ((PEDIACEL) if child is 6 years of age and no Hib dose has been
given at 15 months of age, or
0.5 ml IM of DTaP-IPV (QUADRACEL) if child is 6 years of age and a Hib dose has been
given at 15 months of age, or
0.5ml IM of Tdap (ADACEL) if the child is 7 years of age at time of booster dose. Also give a
dose of IPV if child did not receive their 3
rd
dose of an IPV-containing vaccine after their 4
th

birthday.
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of DPT, DTaP, IPV, Hib or HB - containing
vaccine or to any INFANRIX hexa vaccine component, or to latex.
2. History of Guillain-Barr syndrome (GBS) within 8 weeks of receipt of a tetanus-containing
vaccine.
3. INFANRIX hexa is not indicated for children 7 years of age.
VACCINE COMPONENTS
Aluminum hydroxyphosphate sulfate, L-histidine, polysorbate 80, trace amounts of polymyxin and
neomycin
ADVERSE EVENTS
Local: redness, swelling, pain.
Systemic: fever > 38.3 C, anorexia, restlessness, irritability, persistent or unusual crying.
SPECIAL CONSIDERATIONS
INFANRIX hexa contains only a single dose of HB vaccine (as Engerix) and is not indicated
for infants and children requiring a double dose of hepatitis B vaccine
INFANRIX hexa and PEDIACEL are NOT interchangeable in a primary series.
Hypotonic-hyporesponsive episodes are not a contraindication to diphtheria, tetanus or acellular
pertussis-containing vaccines, and continued immunization with all antigens is recommended.
While the number of Hib doses varies with age of presentation, give INFANRIX hexa as
indicated above, even when doing so provides extra Hib doses for age.

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 2


INDICATIONS (1) Primary series and booster for infants and children 2-59 months of
age who have had one or more doses of PEDIACEL
(2) Primary series for high risk infants who have had doses of
hepatitis B vaccine at birth and 1 month of age
(3) Booster dose at 18 months of age for infants who have received
a primary Infanrix hexa series or a primary PEDIACEL series
INITIAL SERIES O Dose 1: 0.5ml IM
Dose 2: 0.5ml IM
Dose 3: 0.5ml IM
Give doses 1, 2 and 3
2 months apart
+
Dose 4: 0.5ml IM
Give dose 4 twelve months after 3
rd
dose O
REINFORCEMENTS School-entry booster is:
0.5 ml IM of DTaP-IPV (QUADRACEL)O
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of DPT,
DTaP, IPV or Hib--containing vaccine or to any PEDIACEL
vaccine component
2. Children age 7 years and older.
3. History of Guillain-Barr syndrome (GBS) within 8 weeks of
receipt of a tetanus-containing vaccine.
VACCINE
COMPONENTS
Neomycin, streptomycin, polymyxin B, aluminum phosphate, 2-
phenoxyethanol, polysorbate 80, tetanus protein, formaldehyde and
bovine serum.
ADVERSE EVENTS Local: redness, tenderness, swelling.
Systemic: irritability, crying, fever >38.3C, drowsiness, decreased
activity and decreased appetite, vomiting and diarrhea.
SPECIAL
CONSIDERATIONS
Hypotonic-hyporesponsive episodes are not a contraindication to
diphtheria, tetanus or acellular pertussis-containing vaccines, and
continued immunization with all antigens is recommended

O If the childs immunization schedule is delayed, so that the child requires fewer doses of Hib
vaccine, administer QUADRACEL rather than PEDIACEL.
O If required, this dose can be given as early as 6 months following dose number 3. For
protection against Hib, do not give this dose before 15 months of age.
O Dose number 5 should be given 30 to 54 months after dose number 4 and no sooner than
age 4 (the minimum interval between dose 4 and 5 is six months). A 5
th
dose is not
necessary if the 4
th
dose was given after the 4
th
birthday.
Diphtheria -Tetanus - Acellular Pertussis-Polio-Haemophilus Influenzae Type b
Adsorbed (DTaP-IPV-Hib) (PEDIACEL)
Supplier: sanofi pasteur
Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 3



Diphtheria-Tetanus- Acellular Pertussis-Polio Adsorbed (DTaP-IPV)(QUADRACEL)
Supplier: sanofi pasteur
INDICATIONS DOSE
(1) School Entry Booster
(2) Used to complete the primary series and booster for
children in whom Hib is not indicated (see routine Hib
schedule).
(1) 0.5 ml IM O
(2) 0.5 ml IM O
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of DPT, DTaP or
IPV-containing vaccine or to any QUADRACEL

vaccine component
2. Children age 7 years and older.
3. History of Guillain-Barr syndrome(GBS) within 8 weeks of receipt of
a tetanus containing vaccine.
VACCINE
COMPONENTS
Neomycin, polymyxin B, aluminum phosphate, 2-phenoxyethanol,
tween 80, formaldehyde and bovine serum.
ADVERSE EVENTS Minor local: redness, tenderness, swelling, pain
Minor systemic: fever > 38.3 C, anorexia, vomiting, irritability,
drowsiness, listlessness, fretfulness, persistent or unusual crying
SPECIAL
CONSIDERATIONS
Hypotonic-hyporesponsive episodes are not a contraindication to
diphtheria, tetanus or acellular pertussis-containing vaccines, and
continued immunization with all antigens is recommended.
O Not necessary if the 4
th
dose of PEDIACEL, or QUADRACEL was given after the 4
th

birthday.
O An interval of 8 weeks is preferred between doses 1, 2, and 3. An interval of 12 months is
preferred between doses 3 and 4 (minimum interval between dose 3 and dose 4 is six
months.) Dose number 5 should be given 30 to 54 months after dose number 4 and no
sooner than age 4 (the minimum interval between dose 4 and 5 is six months).















Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 4



Haemophilus B Conjugate Vaccine (Act-HIB )
Supplier: sanofi pasteur
INDICATIONSO



(1) All children 2-59 months of age O O

AGE AT PRESENTATIONO INITIAL SERIES REINFORCEMENTS


2 6 months 0.5 ml IM (3 doses)
2 months apart
0.5 ml IM at 18 months O


7 11 months 0.5 ml IM (2 doses)
2 months apart
0.5 ml IM at 18 months O


12 14 months 0.5 ml IM (1 dose) 0.5 ml IM at 18 months O

15 59 months 0.5 ml IM (1 dose) None required O



(2) Unimmunized persons > 5 years of age with the following conditionsOO: anatomic
or functional asplenia; sickle cell disease; immunosuppression related to disease
(e.g., congenital immunodeficiency states such as complement, properdin or factor D
deficiency; malignant neoplasm including leukemia and lymphoma; HIV infection) or
therapy (e.g., high dose, systemic steroids; or severe rheumatoid arthritis requiring
immunosuppressive therapy); candidates or recipients of solid organ or islet cell
transplants, or cochlear implants:







0.5 ml IM (1 dose)
No reinforcement requiredO


(3) Re-immunization following receipt of a hematopoietic stem cell transplant (HSCT)

0.5 ml IM (3 doses) O


CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of a Hib-
containing vaccine or to any component of Act-HIB .
VACCINE COMPONENTS


Tetanus protein and Trometamol.

ADVERSE EVENTS Minor Local: redness, tenderness, swelling, pain.
Minor Systemic: fever > 38.3 C, fussiness, irritability, lethargy,
loss of appetite.
O It is preferable to use the same Hib product for all doses of the primary series. Using
different Hib products during the primary series is acceptable if it is not possible to continue
with the initial product.
O Children who had Hib disease prior to 24 months of age may not have mounted an
adequate immune response for protection against Hib disease and should receive vaccine
according to the schedule consistent with their age.









O If series is interrupted, complete series according to age at which child re-presents.

O The booster recommended at 18 months may be given as early as 15 months provided
there is a 2 month interval following the previous dose.


O At 15 months of age and older, a single dose of any Hib product is all that is required for
protective antibody levels.


O Give vaccine at least 14 days prior to elective splenectomy, or if not possible, 14 or more
days post-splenectomy. If there is concern that the patient may not present later for
immunization, give vaccine before discharge.



O One Hib dose is recommended for asplenics > 5 years of age, regardless of previous Hib
immunization.


O For 3 dose schedule, see BC Communicable Disease Control Manual, Chapter 2, Section
III Immunization of Special Populations, Tables 4 & 5 Adult and Child Immunization Post
Hematopoietic Stem Cell Transplant (HSCT)

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 5


Hepatitis A Vaccine: Indications
Recommended and provided free to:
Individuals with haemophilia A or B receiving plasma-derived replacement clotting factors
and testing negative for anti-HAV IgG. That is, those who do not have evidence of past
hepatitis A infection.
Previously unimmunized anti-HCV positive individuals who are anti-HAV IgG negative.
Previously unimmunized individuals chronically infected with hepatitis B virus who are
anti-HAV IgG negative.
Individuals with other chronic liver disease (including cirrhosis and liver transplant
candidates or recipients, liver damage from hemachromatosis) who are anti-HAV IgG
negative.
Users of illicit injection drugs; persons sharing illicit drug snorting, smoking or injecting
equipment.
Men who have sex with men.
Individuals who are HIV positive.
Inmates of provincial correctional facilities.
Haematopoietic stem cell transplant (HSCT) recipients.
Individuals receiving chronic blood transfusions.
Contacts of a case of hepatitis A: O
Household
Close non-household
Daycare
Drug-sharing
Sexual contacts
Other food handlers at the same establishment if the case is a food handler
Patrons of involved food-handling establishment at risk of hep A as assessed by
Public Health staff.

Recommended but not provided free to:
Travelers, military personnel, and others who will work or live in countries with
intermediate or high endemic rates of HAV infection, especially when travel or work will
involve rural or primitive conditions. O
Food handlers.
Persons with multiple sex partners.
Residents and staff of institutions for developmentally challenged clients where there is an
ongoing problem with HAV transmission.
Zookeepers, veterinarians, and researchers who handle non-human primates; certain
workers involved in research on hepatitis A virus or the production of hepatitis A vaccine.
O One dose of vaccine is to be provided when it is within 14 days after the last exposure to
the case while case was in the infectious period. If a client received 1 dose of hepatitis A
vaccine more than 6 months previously, provide a 2nd dose of hepatitis A vaccine.

O Travelers who opt not to undergo HAV immunization should consider Ig prophylaxis.

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 6


INDICATIONS See Hepatitis A Vaccine Indications
6 months up to and including 18 years of age: O
USING HAVRIX presentation of 720 ELU per 0.5ml
Dose 1: 0.5 ml IM
Dose 2: 0.5 ml IM 6 to 12 months after dose 1

INITIAL SERIES O O






19 years and older:

USING HAVRIX presentation of 1440 ELU per 1.0 ml
Dose 1: 1.0 ml IM
Dose 2: 1.0 ml IM (1440 ELU presentation) or 0.5 ml IM (720 ELU
presentation) 6 to 12 months after dose 1O

REINFORCEMENTS Currently no recommendation for booster dose(s).
CONTRAINDICATIONS
History of an anaphylactic reaction to a previous dose of any hepatitis
A vaccine, to any component of HAVRIX vaccine or to latex (pre-
filled syringe presentation only).
VACCINE
COMPONENTS
Formaldehyde, aluminum hydroxide, 2-phenoxyethanol, polysorbate
20, neomycin B sulphate, potassium chloride, disodium phosphate,
monopotassium phosphate, bovine serum albumin, amino acids.
ADVERSE EVENTS
Tend to be mild and transient.
Local: Soreness and redness at injection site
Systemic: Headache, fatigue, fever, malaise, and gastrointestinal
symptoms
SPECIAL
CONSIDERATIONS
Active immunization with hepatitis A vaccine is the first choice for
protection against hepatitis A for travellers. Given the good serologic
response to vaccine after the primary dose, simultaneous
administration of Ig is not indicated even if the vaccine is given
immediately before departure. Ig may be used for infants < 6 months of
age and individuals for whom the vaccine is contraindicated.

Post vaccination testing is not indicated following a Hepatitis A
vaccine series

Hepatitis A Vaccine (Inactivated Viral) (Havrix )
Supplier: GlaxoSmithKline
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 7



Hepatitis A Vaccine (Inactivated Viral) (Havrix )
Supplier: GlaxoSmithKline
O The hepatitis A vaccines HAVRIX, VAQTA, AVAXIM, AVAXIM Pediatric, and
ViVAXIM are interchangeable at any scheduled dose for children or adults, using the
age-specific dosage for the particular product.
O For HIV positive individuals, provide three doses of vaccine at 0, 1, and 6 months.
O HAVRIX

is licensed for persons 1 year of age. However, numerous studies have
demonstrated the immunogenicity and safety of hepatitis A vaccine for infants at 6
months of age. Immune response may be blunted in some children less than 6 months
of age due to interference with maternally derived antibody. As maternal hepatitis A
antibody status is usually not known, give Ig to all infants <6 months of age who are at
risk for hepatitis A.
O Studies have shown that 720 ELISA units provides an effective booster dose in those
over 19 years of age
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 8


INDICATIONS See Hepatitis A Vaccine Indications
6 months up to and including 17 years of age:

Dose 1: 0.5 ml (25U) IM
Dose 2: 0.5 ml (25U) IM 6 to 18 months after dose 1
INITIAL SERIES
OOOO
18 years of age:

Dose 1: 1.0 ml (50U) IM
Dose 2: 1.0 ml (50U) IM 6 months after dose 1
REINFORCEMENTS Currently no recommendation for booster dose(s)
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of any hepatitis A
vaccine or to any component of VAQTA vaccine or to latex.
VACCINE
COMPONENTS
Bovine albumin, formaldehyde, neomycin B sulphate, aluminum
hydroxide, sodium borate.
ADVERSE EVENTS Tend to be mild and transient.
Local: Soreness and redness at injection site
Systemic: Headache, fatigue, fever, malaise and gastrointestinal
symptoms
SPECIAL
CONSIDERATIONS
Active immunization with hepatitis A vaccine is the first choice for
protection against hepatitis A for travellers. Given the good serologic
response to vaccine after the primary dose, simultaneous administration
of Ig is not indicated even if the vaccine is given immediately before
departure. Ig may be used for infants < 6 months of age and individuals
for whom the vaccine is contraindicated.

Post vaccination testing is not indicated following a Hepatitis A
vaccine series
O The hepatitis A vaccines HAVRIX, VAQTA, AVAXIM, AVAXIM Pediatric, and
ViVAXIM are interchangeable for children or adults at any scheduled dose, using the
age-specific dosage for the particular product.
O Vaqta does not contain a preservative; use immediately and discard any remainder.
O Vaqta is licensed for persons 1 year of age. However, numerous studies have
demonstrated the immunogenicity and safety of hepatitis A vaccine for infants at 6 months
of age. Immune response may be blunted in some children less than 6 months of age due
to interference with maternally-derived antibody. As maternal hepatitis A antibody status
is usually not known, give Ig to all infants < 6 months of age who are at risk for hepatitis A.
O For individuals who are HIV positive, provide three doses of vaccine at 0, 1, and 6 months
Hepatitis A Vaccine (Inactivated Viral) (Vaqta )


Supplier: Merck Frosst
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 9


Hepatitis A Vaccine (Inactivated Viral) (Avaxim)
INDICATIONS See Hepatitis A Vaccine Indications
Supplier: sanofi pasteur
INITIAL SERIES OO Licensed only for those 12 years of age:

Dose 1: 0.5 ml IM (160 antigen units)
Dose 2: 0.5 ml IM (160 antigen units) 6 - 12 months after dose 1
Currently no recommendation for booster dose(s). REINFORCEMENTS
History of anaphylactic reaction to a previous dose of any hepatitis A
vaccine, or to any component of Avaxim vaccine
CONTRAINDICATIONS
Formaldehyde, aluminum hydroxide, neomycin, and 2-phenoxyethanol.
VACCINE
COMPONENTS
ADVERSE EVENTS Tend to be mild and transient.
Local: Soreness and redness at injection site
Systemic: Mild fever, headache, myalgia/arthralgia, gastrointestinal
symptoms.
SPECIAL
CONSIDERATIONS
Active immunization with hepatitis A vaccine is the first choice for
protection against hepatitis A for travellers. Given the good serologic
response to vaccine after the primary dose, simultaneous administration
of Ig is not indicated even if the vaccine is given immediately before
departure. Ig may be used for individuals for whom the vaccine is
contraindicated.

Post-vaccination testing is not indicated following a hepatitis A vaccine
series.
O The hepatitis A vaccines HAVRIX, VAQTA, AVAXIM, AVAXIM Pediatric, and
ViVAXIM are interchangeable for children or adults at any scheduled dose, using the
age-specific dosage for the particular product.
O For individuals who are HIV positive, provide three doses of vaccine at 0, 1, and 6 months



Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 10


INDICATIONS See Hepatitis A Vaccine Indications
INITIAL SERIES OOO 6 months up to and including 15 years of age:

Dose 1: 0.5 ml IM (80 antigen units)
Dose 2: 0.5 ml IM (80 antigen units), 6 to 12 months after dose 1
REINFORCEMENTS Currently no recommendation for booster dose(s).
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of any hepatitis A
vaccine, or to any component of Avaxim Pediatric vaccine
VACCINE COMPONENTS
Formaldehyde, aluminum hydroxide, neomycin, and 2-phenoxyethanol.
ADVERSE EVENTS Tend to be mild and transient.
Local: Soreness, redness, induration, swelling.
Systemic: Mild fever, headache, myalgia/arthralgia, gastro-intestinal
symptoms
SPECIAL
CONSIDERATIONS
Active immunization with hepatitis A vaccine is the first choice for
protection against hepatitis A for travellers. Given the good serologic
response to vaccine after the primary dose, simultaneous
administration of Ig is not indicated even if the vaccine is given
immediately before departure. Ig may be used for infants < 6 months of
age and individuals for whom the vaccine is contraindicated.

Post vaccination testing is not indicated following a Hepatitis A vaccine
series.
O The hepatitis A vaccines HAVRIX, VAQTA, AVAXIM, AVAXIM Pediatric, and ViVAXIM
are interchangeable for children or adults at any scheduled dose, using the age-specific dosage
for the particular product.
O Avaxim Pediatric is licensed for persons 12 months to 15 years of age. However, numerous
studies have demonstrated the immunogenicity and safety of hepatitis A vaccine for infants at 6
months of age. Immune response may be blunted in some children less than 6 months of age
due to interference with maternally-derived antibody. As maternal hepatitis A antibody status is
usually not known, give Ig to all infants < 6 months of age who are at risk for hepatitis A.
O For individuals who are HIV positive, provide three doses of vaccine at 0, 1, and 6 months.


Hepatitis A Vaccine (Inactivated Viral) (Avaxim Pediatric)
Supplier: sanofi pasteur
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 11


Hepatitis B Immune Globulin (HBIg) (BayHep B )
INDICATIONS DOSAGEOO
Supplier: Bayer
(1) Infant born to known HBsAg positive
woman


(2) Infant born to woman at high risk for
hepatitis B infection (i.e., intravenous
drug use, sex trade work)) whose
infectious status is unknown or
negative (possible window period)

(3) Infant < 12 months of age has mother
with acute hepatitis B infection




(4) Percutaneous or mucosal exposure to
HBsAg positive source




(5) Sex with a person who has acute or
chronic hepatitis B infection
(1) Give HBIg 0.5 ml IM immediately after
birth, along with first dose of hepatitis B
vaccine series. O

(2) Give HBIg 0.5 ml IM immediately after
birth, along with first dose of hepatitis B
vaccine series. O



(3) Consider the immune status of the
infant and history of hepatitis B
immunization and give HBIg 0.06ml/kg
of body weight IM and hepatitis B
vaccine as required OOO

(4) Give HBIg 0.06 ml/kg of body weight
and hepatitis B vaccine IM as required,
considering the clients immune status
and history of hepatitis B
immunization. OO

(5) Give HBIg 0.06 ml/kg of body weight
IM as soon as possible following the
last sexual exposure, along with
hepatitis B vaccine series OOO
REINFORCEMENTS An at-risk known non-responder to two
series of vaccine requires 2 doses of HBIG
one month apart
None
CONTRAINDICATIONS











Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 12


Hepatitis B Immune Globulin (HBIg) (BayHep B )
Supplier: Bayer
PRECAUTIONS
Human Ig products are among the safest blood-derived products available. The method of
preparation includes one or more steps that exclude or inactivate hepatitis B, C and HIV;
therefore the risk of transmission is extremely low. However, it is possible that unknown
infectious agents may be present in such products.
Regarding HBIg and the administration of live vaccines see Immune Globulin Preparations
or Blood: Timing Intervals for Vaccines Containing Live Measles, Mumps, Rubella, or
Varicella Virus.
Give HBIg with caution (i.e., in a setting capable of managing anaphylaxis) if the person
has a history of anaphylactic reaction following receipt of any human Ig product, or a
history of anaphylactic reaction to latex (assess risks versus benefits).
Clients with severe thrombocytopenia or coagulation disorders that contraindicate IM
injections should not be given HBIg unless the benefits outweigh the risks.
HBIg does not contain preservatives. Vials are single dose use; discard unused
contents.
HBIg must be given at a separate anatomic site from hepatitis B vaccine.
The preferred site for the administration of HBIg is the ventrogluteal area, which may be
used in those > 7 months of age. However, the vastus lateralis is most often used in
infants and children up to 5 years of age.
ADVERSE EVENTS
Local pain and tenderness at injection site, urticaria and angioedema may occur.
O There is no upper limit to the volume of HBIg that can be administered.
O Provide a written record to a client who receives any immune globulin product.
O There is no outer time limit for administering HBIg in infants <12 months of age, when the infants
exposure to the known risk factor(s) is ongoing. For infants < 8.3 kg, give 0.5 ml HBIg.
O HBIg dose for all clients 8.3kg is 0.06ml/kg. Give HBIg as soon as possible, preferably within 48
hours of the exposure. For a percutaneous exposure, HBIg may be given up to 7days following the
exposure. If the client presents > 7 days following a percutaneous exposure, give Hepatitis B vaccine
only. For permucosal or sexual exposures, HBIg may be given up to 14 days following the last
exposure. If the client presents > 14 days following a permucosal or sexual exposure, give Hepatitis
B vaccine only. Refer to Hepatitis B Post-Exposure Prophylaxis table.
O See Immune Globulin Preparations (HBIg, Ig,VarIg, RabIg) for maximum volume to be administered
per site according to age
O For steady, long term sexual partners of chronic hepatitis B carriers, test for HBsAg, anti-HBc and
anti-HBs to determine if client is susceptible and requires HBIg, or has been infected previously.






Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 13

Vaccination history of
exposed person

Test exposed
person for:
HBsAg, anti-HBc
& anti-HBs.
If source is
HBsAg positive
or tests positive
within 48 hrs of
exposure O
If source is
unknown/not
tested/tests
HBsAg negative
within 48 hoursO
Post-exposure
re-testing
Documented anti-HBs
level (10 IU/L) on prior
testing
Test for all three
markers for
medical-legal
purposes
No action required. No action required. No action required.
Unvaccinated
or
_____________
Known non-responderO
to one Hep B series
Test for all 3
markers
_______________
Test for all 3
markers
Give Hepatitis B
Immune Globulin
(HBIg) O and
Hepatitis B vaccine
series O
Give Hep B
vaccine series
______________
Give 2
nd
Hep B
vaccine series
Re-test for all 3
markers at 6 & 9
months O
Received 1 dose of Hep
B vaccine, anti-HBs
status unknown
Test for all 3
markers
Give HBIg &
complete Hep B
vaccine series.
Complete Hep B
vaccine series.
Re-test for all 3
markers at 6 & 9
months O
Test for all 3
markers.
If anti-HBs is
<10 IU/L, then
Give HBIg & 3rd
dose of Hep B
vaccine. Repeat
3
rd
dose if given
too early in series.
Give 1 dose of
Hep B vaccine &
retest for anti-HBs
in 4 wks; if <10
IU/L repeat series.
Re-test for all 3
markers at 6 & 9
months O
Received 2 doses of a 3
dose Hep B series,
anti-HBs status
unknown



Test for all 3
markers.
If anti-HBs is
10 IU/L, then
Do not give HBIg.
Complete Hep B
vaccine series.
Do not give HBIg.
Complete Hep B
vaccine series.
No re-testing
required.
Complete Hep B
vaccination (2 or 3 dose
series) and anti-HBs
status unknown or anti-
HBs < 10 when tested
> 6 months post-series
Test for all 3
markers.
If anti-HBs is
<10 IU/L, then
Give HBIg and 1
dose of vaccine.
1 dose Hep B
vaccine & retest
for anti-HBs in
4wks; if <10 IU/L
complete second
series.
Re-test for all 3
markers at 6 &
9months O
Known non-responderO
after two courses of Hep
B vaccine
Test for HBsAg &
anti-HBc. Do not
test for anti-HBs.
Give HBIg only &
give another dose
of HBIg in 1 mo.
No action required.

Re-test for all three
markers at 6 & 9
months.
O A non-responder to a series of Hepatitis B vaccine is someone who demonstrates an anti-HBs level of
< 10 UI/L, when measured 1 to 6 months post-vaccination.
O Consensual adult sex with known STW or IDU is not an indication for HBIg, nor is a community acquired needlestick
injury: the risk of transmission is low and the number needed to treat to prevent infection is extremely high. HBIg is
indicated in the case of sexual assault or if one of the individuals is known to have acute or chronic Hepatitis B infection.
O HBIg dose for all clients 8.3kg is 0.06ml/kg. Give HBIg as soon as possible, preferably within 48 hours of the exposure.
For a percutaneous exposure, HBIg may be given up to 7days following the exposure. If the client presents > 7 days
following a percutaneous exposure, give Hepatitis B vaccine only. For permucosal or sexual exposures, HBIg may be
given up to 14 days following the last exposure. If the client presents > 14 days following a permucosal or sexual
exposure, give Hepatitis B vaccine only.
O Hepatitis B vaccine schedule is 0, 1 and 6 months for post-exposure prophylaxis.
O A second series of Hepatitis B vaccine should be offered to non-responders

Note: This table does not apply to post-exposure management of immunocompromised persons. This group requires
consultation with a physician specializing in infectious diseases.
Table 5: Hepatitis B Post-Exposure Prophylaxis


Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 14


Hepatitis B Vaccine Pre-exposure Indications
Provided free to: OO
Grade 6 students.
Children born on or after January 1, 2001.
Children under 12 years of age who are new immigrants (within the past year) to Canada from
regions of high hepatitis B prevalence (e.g. Asia and Africa).
Household contacts of internationally adopted children
Students of selected health care professions O See Hepatitis B Vaccine for Students of Health
Care Professions
Users of illicit injectable drugs and their sexual partners.
Persons sharing illicit drug snorting, smoking or injecting equipment.
Males who have sexual contact with other males.
Individuals who are HIV positiveO
Persons with multiple sexual partners or recent history of a sexually transmitted infection (STI).
Anti-HCV positive individuals who do not have past or current evidence of hepatitis B infection.
Individuals with chronic liver disease (including cirrhosis, candidates or recipients of liver transplant,
and liver damage from hemachromatosis) who do not have past or current evidence of hepatitis B
infection. O
Hemophiliacs and others receiving repeated infusions of blood or blood products.
Inmates of provincial correctional facilities.
Individuals with chronic kidney disease (predialysis, hemodialysis, and peritoneal dialysis clients) O
and candidates or recipients of a kidney transplant. O
Receipt of a hematopoietic stem cell transplant (HSCT) O
Previously unimmunized teachers and classroom contacts of developmentally challenged known
hepatitis B carriers whose behavior or medical condition increases risk to others.
Previously unimmunized children and staff in childcare settings in which there is a child infected
with hepatitis B.
Staff and residents in community group homes for the developmentally disabled.
Pharmacists who will be providing injections.
Provided free by employers for Health Care Workers and others at occupational risk of exposure to
blood or body fluids (e.g. dentists, dental hygienists, assistants and technicians, etc.)
Recommended but not provided free to:
Persons visiting countries with high HBV endemicity areas and staying 6 months and/or having
sexual or blood contact with local residents regardless of length of stay.
Population or communities in which HBV is highly endemic.
O Since September 1992, BC has implemented a grade 6 hepatitis B immunization program; therefore most
individuals born in 1980 through present day are immunized. If no records are available and the client is
unable to recall receiving hepatitis B vaccine, proceed with hepatitis B vaccination as per indication.
O Prevaccination testing for HBsAg, anti-Hbc and anti-HBs is recommended for persons at high risk of having
been infected (i.e., IDU, STW, individuals with HCV or chronic liver disease, and persons born in countries of
high hepatitis B prevalence).
O Responsibility for administration lies with the educational institution. However, at the discretion of the
individual Health Region, staff may administer vaccine.
O Require a double g dose for age.

O Hemodialysis clients require a specific hepatitis B vaccine dosage and series. See Hepatitis B Vaccine
Program for Chronic Kidney Disease Clients.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 15


The following students of health care professions are eligible for hepatitis B vaccine:
Undergraduate Medicine
Undergraduate Nursing
Undergraduate Dentistry
Undergraduate Pharmacy
Students training to be:
- Biomedical Engineers
- Blood Perfusion Technologists
- Community Support Workers
- Corrections Officers
- Cytogeneticists
- Dental Assistants
- Dental Hygienists
- Dental Technicians
- Electrophysiologists (human)
- Embalmers and Funeral Directors
- EMT/paramedics
- Health Science Students (University Departments of Anatomy)
- Licensed Practical Nurses
- Long Term Care Attendants
- Medical Laboratory Technicians
- Medical Office Assistants
- Midwives
- Nurses' Aides
- Personal Care Attendants
- Radiology Technicians
- Rehabilitation Medicine Specialists
- Respiratory Therapists
- Residential Care Aides
- Sterile Supply Workers

Note: Individuals who received hepatitis B vaccine years prior to enrolment as a student in a
health care profession or years prior to employment as a health care worker may be tested
to determine protective status for hepatitis B. If anti-HBs is < 10IU/L but is detectable,
provide one dose of vaccine and retest 4 weeks after this dose. If level is 10 following this
dose, no further vaccine is required. When anti-HBs is <10 IU/L after this one dose,
complete the second vaccine series and retest 4 weeks after the last dose.
Hepatitis B Vaccine for Students of Health Care Professions

Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 16


Hepatitis B Vaccine (Engerix-B)
Supplier: GlaxoSmithKline
Pediatric presentation 10 mcg/0.5 ml; adult presentation 20mcg/1.0 ml
INDICATIONS INITIAL SERIES OOOOOO
(1) See Hepatitis B Vaccine Pre-
exposure Indications
(2) See Hepatitis B Vaccine Post-
exposure Indications
(3) Use when there is a
contraindication to
RecombivaxHB or when
RecombivaxHB is not available



(4) Routine grade 6 program and
adolescents 11 years of age,
but 15 years of age.
(1) (2) & (3)
Infants from birth, children, and adolescents to 19 years
of age inclusive (except the routine infant program,
neonates who will be contacts of chronic carriers, and the
routine grade 6 program.)
0.5 ml IM (10 mcg) at 0, 1 and 6 monthsO

Eligible adults 20 years of age
1.0 ml IM (20 mcg) at 0, 1 and 6 months


(4) 1.0 ml IM (20 mcg) at 0 and 6 months
(Use adult single dose formulation)O
REINFORCEMENTS None
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of any
hepatitis B vaccine or to any component of Engerix-B.
Aluminum hydroxide, and traces of yeast. ThimerosalO
VACCINE COMPONENTS
ADVERSE EVENTS Fever ( 37.7C) and mild short-term soreness at injection
site.
O Engerix-B & RecombivaxHB are interchangeable at any dose, using age-specific
dosage and recommended schedule for the respective product. There must be a minimum
of 6 months between doses 1 and 2 whenever both products are used in a 2-dose series.
O The single dose pediatric formulation (10 mcg/0.5 ml vial) and the adult single dose
(20 mcg/1.0 ml) formulation are thimerosal-free.
O A minimum of 1 month must pass between dose 1 and 2. Dose 3 must be given at least 4
months after the 1
st
dose and 2 months after the 2
nd
dose. This change to the minimum
intervals was effective as of June 2007. Prior to this date the minimum interval was 4 weeks
between each dose. If the immunization series is interrupted after the 1st dose, the 2nd
dose should be administered as soon as possible. If only the 3rd is delayed, administer as
soon as possible. If years have lapsed between the 1st and 2nd dose, it may be prudent to
assess antibody response post series, especially if the client is at significant risk.
O Hemodialysis clients require a specific hepatitis B vaccine dosage and series (see
Hepatitis B Vaccine Program for Chronic Kidney Disease Clients).
O Immunocompromised clients require a double dose of Hepatitis B vaccine for all
indications.
O High risk infants who receive a birth dose of Hepatitis B vaccine and/or HBIg can complete
their vaccine series with INFANRIX hexa at 2, 4 and 6 months of age. Infants who have
been given doses of Hepatitis B vaccine at birth and 1 month of age should be given
PEDIACEL vaccine at 2, 4 and 6 months of age, and a 3
rd
dose of Hepatitis B vaccine at
6 months of age. These infants weighing < 2000 grams at birth will require a 4
th
dose of
Hepatitis B vaccine at 8 months of age.
O There must be a minimum of 6 months between doses 1 and 2.

Communicable Disease Control
Immunization Program
Section VII Biological Products
December 2010
Page 17



Hepatitis B Vaccine Pre-Exposure (RecombivaxHB) (10 mcg/1.0 ml)
(Pediatric presentation: 5 mcg/0.5 ml, thimerosal free)
Supplier: Merck Frosst
INDICATIONS INITIAL SERIES OOOO
(1) Infants, including infants weighing
< 2000 grams at birth, whose
father or other primary caregiver
or household contact has chronic
hepatitis B infection.
Use thimerosal free vaccine.
(1) Give 0.5ml IM (5mcg) at birth

Give INFANRIX hexa at 2 - 4 - 6 months O
(2) Infants who are part of the routine
Hepatitis B program and
receiving PEDIACEL in the
primary series
Use thimerosal free vaccine.
(2) 0.5 ml IM (5 mcg) at 2-4-6 months.
(3) Infants and children and
adolescents to19 years of age
inclusive (except the routine
infant program, neonates who will
be contacts of chronic carriers,
and the routine grade 6 program).
Use thimerosal free vaccine.
(3) 0.5 ml IM (5 mcg) at 0-1-6 months

(4) Routine grade 6 program and
adolescents 11years of age, but
15 years of age.
Use thimerosal free vaccine.
(4) 1.0 ml IM (10 mcg) at 0 and 6 monthsO

(5) Eligible adults 20 years of age. (5) 1.0 ml IM (10 mcg) at 0-1-6 months.
REINFORCEMENTS None.
History of anaphylactic reaction to a previous dose of any
hepatitis B vaccine, to any component of RecombivaxHB
or to latex.
CONTRAINDICATIONS
VACCINE COMPONENTS Aluminum hydroxide, formaldehyde, yeast, and thimerosal
when the 3 mL vial presentation is used.
ADVERSE EVENTS Fever ( 37.7 C) and mild short-term soreness at injection
site.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 18


Hepatitis B Vaccine Pre-Exposure (RecombivaxHB) (10 mcg/1.0 ml)
(Pediatric presentation: 5 mcg/0.5 ml, thimerosal free)
Supplier: Merck Frosst

O Engerix-B & RecombivaxHB are interchangeable at any dose, using age-specific
dosage and recommended schedule for the respective product. There must be a minimum
of 6 months between doses 1 and 2 whenever both products are used in a 2-dose series.
O A minimum of 1 month must pass between dose 1 and 2. Dose 3 must be given at least 16
weeks after the 1
st
dose and 8 weeks after the 2
nd
dose. This change to the minimum
intervals was effective as of June 2007. Prior to this date the minimum interval was 4
weeks between each dose. If the immunization series is interrupted after the 1st dose, the
2nd dose should be administered as soon as possible. If only the 3rd is delayed, administer
as soon as possible. If years have lapsed between the 1st and 2nd dose, it may be
prudent to assess antibody response post series, especially if the client is at significant
risk.
O Hemodialysis clients require a specific hepatitis B vaccine dosage and series (see Hepatitis
B Vaccine Program for Chronic Kidney Disease Clients)
O Immunocompromised clients require a double g dose of hepatitis B vaccine for all
indications. A 0.5 ml (5mcg) Recombivax HB dose represents a double dose for
infants and children < 11 years of age.
O Infants who have been given doses of Hepatitis B vaccine at birth and 1 month of age
should be given PEDIACEL vaccine at 2, 4 and 6 months of age, and a 3
rd
dose of
Hepatitis B vaccine at 6 months of age. These infants weighing < 2000 grams at birth will
require a 4
th
dose of Hepatitis B vaccine at 8 months of age.
O While a second dose can be given 4 6 months following the first dose, the dose is
suggested at 6 months for consistent timing with other vaccine programs in this grade.



Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 18a


Hepatitis B Vaccine Options for 2010/2011 Grade 6 Series Completion
VACCINES O DOSE
(1) RecombivaxHB (1) 1.0 ml IM (two vials of the pediatric presentation)
6 months following the first hepatitis B vaccine (5 mcg/0.5ml) pediatric
presentation doseOO

(2) 1.0 ml IM 6 months following the first hepatitis B
vaccine dose

(2) Engerix-BO
(20 mcg/1.0 ml) single dose
adult presentation

(3) 1.0 ml IM 6 months following the first hepatitis B
vaccine doseO
(3) RecombivaxHB O
(10 mcg/1.0 ml) single dose
presentation

REINFORCEMENTS None
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of
any hepatitis B vaccine or to any component of
Engerix-B or RecombivaxHB.

Anaphylactic reaction to latex is a contraindication to
RecombivaxHB
VACCINE COMPONENTS
Engerix B: Aluminum hydroxide and traces of yeast.

RecombivaxHB: Aluminum hydroxide, formaldehyde,
yeast.
ADVERSE EVENTS Fever ( 37.7C) and mild short-term soreness at injection
site.
O All of the listed hepatitis B vaccine presentations are thimerosal free.

O Use stringent aseptic technique when drawing up 1 dose from 2 separate vaccine vials.

O A second dose using a RecombivaxHB vaccine can be given 4 to 6 months after the first
dose, when a RecombivaxHB vaccine was given as the first dose.

O Single dose Engerix B (20mcg/1.0 ml) and RecombivaxHB (10 mcg/1.0 ml) are preferred
for the grade 6 program and should be used for this program when supplies become available.

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 19



Hepatitis B Vaccine Post-Exposure Indications

Provided free to: O

Infant born to known HBsAg + mother. Give HBIg and hepatitis B vaccine at birth.O
Infant born to a mother who is at high risk for hepatitis B infection (intravenous drug use
or sex trade work) and her infectious status at delivery is unknown or negative
(possible window period); give HBIg and hepatitis B vaccine at birth. O
Infants born to mother who has risk factors (other than IDU and/or STW) for hepatitis B
infection and her infectious status at delivery is unknown or negative (possible window
period). Give hepatitis B vaccine at birth. O
Infant whose father or other primary care giver or household contact has chronic
hepatitis B infection. Give hepatitis B vaccine at birth. O
Infants from birth to < 12 months of age if father or other primary caregiver are at high
risk for hepatitis B infection and their infectious status is unknown or negative (possible
window period). Give hepatitis B vaccine at birth. O
Infant < 12 months of age whose mother has acute hepatitis B. OO
Household contacts (including infants)O of acute case or chronic carrier.O
Sex with a person who has acute or chronic hepatitis B infection. OOO
Percutaneous or mucosal exposure in the community (i.e. sexual assault, needle
sticks) and household contacts with percutaneous or mucosal exposure (i.e. sharing of
toothbrushes or razors) of acute or chronic hepatitis B infection. OO
O Refer to Hepatitis B Post-Exposure Prophylaxis table to assess need for HBIg and
hepatitis B vaccine.
O Post-vaccination testing (HBsAg and anti-HBs) of infants must be performed 1 month
after completion of the hepatitis B vaccine series. If HBsAg is found, the infant is likely
to become a chronic carrier. If the infant is negative for HBsAg and anti-HBs, a 2
nd

series of hepatitis B vaccine should be given and serological testing repeated 1 month
post-series (see post-exposure hepatitis B vaccine pages for dosage and schedules).
O For steady long-term sexual partners of chronic HBV carriers, test for HBsAg, anti-HBc
and anti-HBs prior to administering HBIG. If the client is susceptible to HBV, give HBIg
as soon as possible and no later than 14 days of last sexual exposure.
O Post-vaccination testing should be performed 1 month after completion of the hepatitis
B vaccine series for steady sexual partners of HBV chronic carriers, household
contacts of acute and chronic carriers, sexual assault victims and those with
percutaneous or mucosal exposures.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 20


Hepatitis B Vaccine Post Exposure (RecombivaxHB) (10 mcg/1.0 ml)
(Pediatric presentation: 5 mcg/0.5 ml, thimerosal free)
Supplier: Merck Frosst
INDICATIONS INITIAL SERIESOOOO
(1) Infants born to HBsAg positive mothers
(2) Infant weighing < 2000 grams at birth and
requiring a birth dose of hepatitis B vaccine
(3) Infant whose mother is at high risk and
infectious status unknown
(4) Infant whose caregiver or household contact
is a chronic hepatitis B carrier

(1) (2) (3) & (4)O

Give 0.5 ml IM (5 mcg) at birth
Use thimerosal free vaccine

Give Infanrix hexa at 2-4-6 months.

POST EXPOSURE SCHEDULE FOR OTHER
INDICATIONS
(1) Infants and children 15 years of age. Use
thimerosal free vaccine.O
0.5 ml IM (5 mcg) at 0-1-6 months.

(2) Adolescents 16 and < 20 years of age.O
0.5 ml IM (5 mcg) at 0-1-6 months.

(3) Adults 20 years of age.O
1.0 ml IM (10 mcg) at 0-1-6 months.
SPECIAL CONSIDERATIONS Routine information regarding RecombivaxHB
vaccine is located on the pre-exposure vaccine
page (e.g. vaccine interchangeability,
contraindications, precautions, schedule
variations, etc).
O Hemodialysis clients require a specific dose and series (See Hepatitis B Vaccine Program for
Chronic Kidney Disease Clients)
O Immunocompromised clients (e.g., HIV) require a double dose of hepatitis B vaccine for all
indications.
O Post-vaccination testing (HBsAg and anti-HBs) should be performed 1 month after completion
of the hepatitis B vaccine series. If HBsAg is found, the child is likely to become a chronic
carrier. If the infant is negative for HBsAg and anti-HBs, a 2
nd
series of hepatitis B vaccine
should be given and serological testing repeated 1 month post 2
nd
series. See Hepatitis B
Control Policy for serologic testing for all other groups (i.e., baseline and post exposure).
O Engerix-B & RecombivaxHB are interchangeable at any dose, using age-specific dosage
and recommended schedule for the respective product. There must be a minimum of 6 months
between doses 1 and 2 whenever both products are used in a 2-dose series
O Infants who have been given doses of Hepatitis B vaccine at birth and 1 month of age
should be given PEDIACEL vaccine at 2, 4 and 6 months of age, and a 3
rd
dose of
Hepatitis B vaccine at 6 months of age. These infants weighing < 2000 grams at birth will
require a 4
th
dose of Hepatitis B vaccine at 8 months of age.

O Post-exposure vaccine schedules are individualized based on a number of factors (e.g.
immune status of client and history of hepatitis B immunization) See Hepatitis B Post-Exposure
Prophylaxis table.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 21



Chronic hemodialysis clients are at high risk for HBV infection because the process of
hemodialysis requires vascular access for prolonged periods. In an environment where multiple
clients receive dialysis concurrently, repeated opportunities exist for person-to-person
transmission of infectious agents, directly or indirectly via contaminated devices, equipment and
supplies, environmental surfaces or hands of personnel. Furthermore, hemodialysis clients are
immunosuppressed, which increases their susceptibility to infection.

ELIGIBILITY
All predialysis, hemodialysis and peritoneal dialysis clients in hospital, community, home or self-
care settings are eligible for this program. Vaccine administration should occur at the dialysis
facility; however, in small communities the local health unit may arrange it.
PRE-DIALYSIS AND DIALYSIS CLIENTS O O
RECOMBIVAX HB Engerix-B
Age Dose Volume Schedule Dose Volume Schedule
20 years 1.0 ml 0, 1 and 6
months
40 mcg 40 mcg O 2.0 ml 0, 1, 2 and 6
months
7 19
years
1.0 ml 0, 1 and 6
months
20mcg 1.0 ml 10 mcgO 0, 1, 2 and 12
months
Birth 6
years
0.5 ml 0, I and 6
months
5 mcg O 20 mcg O 1.0 ml 0, 1, 2 and 12
months
Post-vaccination serology: measure anti-HBs 1 month after completion of a primary series. If
anti-HBs is < 10 IU/L, the client is a non-responder. Provide a second vaccine series and
assess anti-HBs. If anti-HBs is <10 IU/L, the client, as a non-responder to 2 vaccine series, is
susceptible to hepatitis B. There is no benefit to further vaccination. If an exposure to
blood or body fluids occurs, the client will require post-exposure prophylaxis.
O All doses of hepatitis B vaccine should be administered in the deltoid by the IM route, or for
infants <12 months of age, in the vastus lateralis.
O Pre-dialysis clients and dialysis clients receive the same dose volume of hepatitis B vaccine
because there is no discrete level of renal function that correlates well with vaccine
immunogenicity.
O Special formulation for adult dialysis clients.
O Use adult formulation (10mcg/1.0ml).
O Use thimerosal-free RecombivaxHB or pediatric Engerix-B formulation. Dosage for this
age group is based on NACI guidelines.

NOTE: If a client has received Engerix-B vaccine as dose 1, the client will require a 4 dose
series regardless of which vaccine is used to complete the series. If a client has received
RecombivaxHB vaccine as dose 1, the client will only require a 3 dose series regardless of
which vaccine is used to complete the series.

For ongoing management, see BC Communicable Disease Control Manual, Chapter 2,
Section III, Chronic Kidney Disease and Dialysis Clients

Hepatitis B Vaccine Program for Chronic Kidney Disease Clients
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 22



Hepatitis A and B Vaccine Combined (Inactivated Viral) (Twinrix )
Supplier: GlaxoSmithKline OO
INDICATIONS INITIAL SERIESO
Recommended but not provided
free to:

(1) Persons 6 months to 15 years
old who do not qualify for a
Ministry of Health funded
Hepatitis A and/or Hepatitis B
Immunization Program

(2) Persons >18 years old who do
not qualify for a Ministry of
Health funded Hepatitis A and/or
Hepatitis B Immunization
Program.




(1) Persons 6 months to 15 years old :
(a) See schedule for Twinrix Junior.
(b) Alternative schedule with Twinrix:
1.0 ml IM at 0 months and 6 - 12 months



(2) Persons >18 years old:
(a) 1.0 ml IM at 0, 1 and 6 months
(b) Rapid dosing schedule: 1.0 ml IM at
0721 days
REINFORCEMENTS (1) (a) None
(2) (a) None
(b) For rapid dosing schedule: 12 months after
dose 1
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of
any hepatitis A or hepatitis B-containing vaccine, to
any component of Twinrix vaccine, or to latex.
Neomycin sulfate, formaldehyde, aluminum
hydroxide, aluminum phosphate, 2-phenoxyethanol,
polysorbate 20, and traces of yeast.
VACCINE COMPONENTS
ADVERSE EVENTS Local: rarely, redness, swelling and pain
Systemic: fever ( 37.7 C), headache, malaise,
fatigue, nausea
O Each 1.0 ml dose contains Havrix 720 ELU and Engerix-B 20 mcg
O If a client is to be given monovalent hepatitis A vaccine in place of a dose (or doses) of
Twinrix, the following vaccines may be used: HAVRIX, VAQTA, AVAXIM, or
AVAXIM Pediatric, administering the age-specific dosage for the particular product. If a
client is to be given monovalent hepatitis B vaccine in place of a dose (or doses) of
Twinrix, the following vaccines may be used: Engerix-B or RecombivaxHB
administering the age-specific dosage and number of doses for the particular product.
O The preferred injection site for children and adults is the deltoid muscle. For those <12
months of age, the preferred site is the vastus lateralis. The vaccine should not be
administered in the gluteal region.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 23


Hepatitis A and B Vaccine Combined (Inactivated Viral) (Twinrix Junior)
Supplier: GlaxoSmithKlineO
INDICATIONSOOO Recommended but not provided free to:

(1) Persons 6 months and 18 years of age who do not qualify
for a Ministry of Health funded Hep A and/or Hep B Immunization
Program.
INITIAL SERIES (1) 0.5 ml IM at 0 - 1 - 6 months.

Rapid dosing schedule: 0.5 ml IM at 0 7 21 days
REINFORCEMENTS (a) None for completed series.

(b) For rapid dosing schedule: 12 months after dose 1
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of any hepatitis A
or hepatitis B-containing vaccine or to any component of Twinrix
Junior vaccine, or to latex.
VACCINE
COMPONENTS
Neomycin sulfate, formaldehyde, aluminum hydroxide, aluminum
phosphate, 2-phenoxyethanol, polysorbate 20 and traces of yeast.
ADVERSE EVENTS Local: rarely, redness, swelling and pain.
Systemic: fever ( 37.7 C), headache, malaise, fatigue, nausea
O Each 0.5 ml dose contains Havrix360 ELU and Engerix-B 10 mcg.
O If a client is to be given monovalent hepatitis A vaccine in place of a dose (or doses) of
Twinrix, the following vaccines may be used: HAVRIX, VAQTA, AVAXIM, or
AVAXIM Pediatric, administering the age-specific dosage for the particular product. If a
client is to be given monovalent hepatitis B vaccine in place of a dose (or doses) of
Twinrix, the following vaccines may be used: Engerix-B or RecombivaxHB,
administering the age-specific dosage and the number of doses for the particular product.
O The preferred injection site for children and adults is the deltoid muscle. For those < 12
months of age, the preferred site is the vastus lateralis . The vaccine should not be
administered in the gluteal region
O Twinrix Junior

is licensed for persons 1 year of age. However, numerous studies have
demonstrated the immunogenicity and safety of hepatitis A vaccine for infants at 6 months
of age. Immune response may be blunted in some children less than 6 months of age due
to interference with maternally derived antibody. As maternal hepatitis A antibody status is
usually not known, give Ig to all infants <6 months of age who are at risk for hepatitis A.



Communicable Disease Control
Immunization Program
Section VII Biological Products
December 2010
Page 24



Human Papillomavirus Vaccine (GARDASIL)
[Quadrivalent (Types 6, 11, 16, 18) Recombinant]
Supplier: Merck Frosst
INDICATIONS INITIAL SERIES O O O O

(1) Girls in grade 6 starting September 1,
2010 (extended dose schedule) O O

(2) Girls 13 years of age at series
commencement who did not receive their
HPV vaccine in Grade 6 (extended dose
schedule) O O


(3) Girls in grade 9O
(the 2010-2011 school year is the last year of
the grade 9 program)


(4) Other females born in 1994 or later, who
are 14 years of age or older, and who
missed receiving or completing a vaccine
series while in grade 6 or 9 in BCO



(5) Other females 9 years to 26 years of
age: HPV vaccine is recommended by the
National Advisory Committee on
Immunization (NACI) BUT is not currently
provided free.


(1)(2) 2 doses in grade 6 ( or later):
0.5 ml IM
0.5 ml IM (minimum of 6 months
after dose one)

3
rd
dose: 0.5 ml IM in grade 11 (or 60
months after dose 2)


(3) 3 doses: 0.5 ml IM
0.5 ml IM at 2 months
0.5 ml IM at 6 months O


(4) & (5) Females 9 years to 26 years of
age
[those with years of birth 1984 through 2001
who do not have indications (1) (2) or (3)]
3 doses: 0.5 ml IM
0.5 ml IM at 2 months
0.5 ml IM at 6 months
OR
3 doses: 0.5 ml IM
0.5 ml IM at 6 months
0.5 ml IM at 12 months O
REINFORCEMENTS
The duration of vaccine protection is unclear. Current studies (with five-year follow up) indicate
that the vaccine is effective for at least five years. This information will be updated as additional
data regarding duration of immunity become available.
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of HPV vaccine, or to any component of
GARDASIL
2. Pregnancy. The vaccine should not be given during pregnancy because safety of receipt of
HPV vaccine during pregnancy has not been adequately studied. Women who become pregnant
before series completion should defer immunization until no longer pregnant. In pregnant women
who are inadvertently vaccinated, there is no need to consider any intervention except
reassurance, as the vaccine has not been associated with teratogenicity.O
Communicable Disease Control
Immunization Program
Section VII Biological Products
December 2010
Page 25

Human Papillomavirus Vaccine (GARDASIL)
[Quadrivalent (Types 6, 11, 16, 18) Recombinant]
Supplier: Merck Frosst
SPECIAL
CONSIDERATIONS
Women for whom HPV vaccine is recommended may be immunized
even if already sexually active, or if they have had previous Pap
abnormalities (including cervical cancer), genital warts, or known HPV
infection. This is because the likelihood that they have been infected
with all four types of HPV contained in the vaccine is low and they
stand to benefit from immunization.O
Sexually active vaccine recipients should continue to be routinely
screened for cervical cancer.
VACCINE
COMPONENTS
Amorphous aluminum hydroxyphosphate sulfate, L-histidine,
polysorbate 80, sodium borate, yeast.
Local: mild to moderate pain, redness, swelling ADVERSE EVENTS
Systemic: headache
O Females born in 1994 and later who are unimmunized or incompletely immunized remain
eligible for HPV vaccine. However, only girls in grade 6 or girls who missed the HPV vaccine in
Grade 6 and are 13 years of age at series commencement will receive HPV vaccine according to
the extended dose schedule. At the discretion of local health authorities, immunization may take
place in health units,
rather than the school setting.
O Grade 6 girls who are known to have immune system defects associated with solid organ
transplant, stem cell transplant, or HIV infection should receive HPV vaccine in the three dose
schedule at 0, 2 and 6 months. The immunosuppressed state results in a less robust immune
response, and those with such conditions are at risk of persistent HPV infection and associated
HPV disease if they become infected.
O Currently, routine HPV testing is not recommended before or after immunization. In addition,
serologic tests are not routinely available in Canada.
O Females who are immunocompromised, either from disease or medication, can receive this
vaccine; however, the immune response to vaccination and vaccine efficacy might be less than in
immunocompetent females.
O Gardasil vaccine can be administered at the same visit as other age-appropriate vaccines,
using a separate needle and syringe for each injection.
O If the schedule is interrupted, the vaccine series does not need to be restarted. If the series is
interrupted after any dose, the subsequent dose should be given as soon as possible. The
minimum interval schedule between dose one and dose two is 4 weeks, and between dose two
and dose three is 12 weeks The minimum interval schedule should not be followed on a routine
basis; it should only be used at the client specific level based on health care provider
assessment. The preferred schedule is 0 2 6 months.
O In FHA during the 2009/10 school year, girls in grades 6 and 9 received only two doses with
the third dose given in the 2010/11 school year to accommodate pandemic influenza mass
immunization. General principles for vaccine series are that longer intervals between doses are
not known to result in lower response rates to the series. However, while different schedules of
this vaccine are under study, adherence to recommended schedules is advised.
O Merck Frosst Canada Ltd. Maintains a Pregnancy Register to monitor fetal outcomes of
pregnant women exposed to GARDASIL vaccine. Patients and health care providers are
encouraged to report any such exposure during pregnancy by calling 1-800-567-2594. See
product monograph for more details.

O Advise vaccine recipients that there are no data to suggest the vaccine will have any
therapeutic effect on existing cervical lesions (i.e., vaccine does not prevent the consequences of
current HPV infection).
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 26


Immune Globulin (Ig) (GamaSTAN S/D)
Supplier: Talecris Biotherapeutics, Inc.


INDICATIONSO

DOSEO

1) Recommended and provided free for post-exposure prophylaxis of
Hepatitis A contacts for whom hepatitis A vaccine is
contraindicated:
a) Household, close non-household, drug-sharing, and sexual
contacts, as well as to co-workers if the case is a food handler,
provided it is within 14 days after the last exposure to the case
while the case was in the infectious period O
b) Refer to the Hepatitis A Control Policy for guidelines pertaining to
exposures in day care centres, institutions for the developmentally
challenged and correctional facilities.



(1) a) 0.02 ml/kg IM




(1) b)0.02 ml/kg IM

2) Recommended and provided free for post-exposure prophylaxis of
measles contacts: O
a) susceptible infants under 1 year of age


b) susceptible pregnant women
c) susceptible immunocompetent contacts who have never been
immunized and who present more than 72 hours, but less than 7
days, after exposure (i.e., too late for vaccine)
d) susceptible immunocompromised contacts
e) those for whom MMR is contraindicated

Note: Administer preferably within 3 days, and no later than 6 days after
exposure to modify or prevent measles disease



(2) a), b), c):
0.25 ml/kg IM
(max. 15 ml)


(2) d), e):
0.5 ml/kg IM
(max. 15 ml)
(3) Pre-exposure prophylaxis against hepatitis A (not provided free):
a) Ig may be indicated for infants < 6 months old and for persons in whom hepatitis A vaccine is
contraindicated when traveling to areas with intermediate or high endemic rates of HAV.
Dose of Ig varies according to needed duration of protection:
< 3 months: 0.02 ml/kg
> 3 months: 0.06 ml/kg prior to exposure and then every 4-6 months if
exposure continues

CONTRAINDICATIONS

1. Do not give Ig intravenously
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 27



Immune Globulin (Ig) (GamaSTAN S/D)
Supplier: Talecris Biotherapeutics, Inc.
PRECAUTIONS
Human Ig products are amongst the safest blood-derived products available. As the
method of preparation includes one or more steps that exclude or inactivate hepatitis B, C
and HIV, the risk of transmission is considered to be extremely low. However, it is possible
that unknown infectious agents may be present in such products.
Persons with severe thrombocytopenia or coagulation disorders that contraindicate IM
injections should not be give IM Ig unless the benefits outweigh the risks.
Give Ig with caution (i.e., in a setting capable of managing anaphylaxis) if the client has a
history of anaphylactic reaction following receipt of any human Ig product, or history of
anayphylactic reaction to glycine or to latex (assess risks versus benefits).
Persons with IgA deficiency have the potential for developing antibodies to IgA and could
have an anaphylactic reaction to subsequent administration of blood products that contain
IgA. Therefore, Ig should only be given to such persons if the expected benefits outweigh
the risks.
Ig contains no preservatives. Vials are single use. Once entered, discard any unused
contents.
Divide large volumes of Ig into two or more sites. See Immune Globulin Preparations (HBIg,
Ig, TIg, VarIg, RabIg).
The preferred site for the administration of Ig is the ventrogluteal area, which may be used
in those > 7 months of age. However, the vastus lateralis is most often used in infants and
children up to 5 years of age.
If administration of Ig is necessary less than 14 days after MMR or varicella vaccine,
repeat vaccine as per recommended intervals as in Immune Globulin Preparations or
Blood: timing intervals for vaccines containing live measles, mumps, rubella or varicella
virus.
ADVERSE EVENTS
Local: pain and injection site tenderness
O Provide a written record to individuals who receive any immune globulin product.
O See Immune Globulin Preparations (HBIg, Ig, VarIg, RabIg) for maximum volume to be
administered per site according to age.
O Immune globulin should be given as soon as possible after a known exposure and no later
than 2 weeks after the exposure.
O When clinical measles does not develop in a person given Ig, a measles-containing
vaccine should be given 5 months later, provided the person is 1 year of age and there
are no contraindications to the vaccine. If the person is immunocompromised, give a
measles containing vaccine 6 months later with physician referral.


Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 28



Immune Globulin Preparations (HBIg, Ig, TIg, VarIg, RabIg)




CLIENT AGE

NEEDLE
Length

SITE

ROUTE
SIZE MAX.VOL
PER SITE (Gauge)

INFANTS
<12 months

7/8" - 1"

25

VentroglutealO O
Vastus lateralis


IM
IM

1 ml
1 ml

CHILDREN

1" 22 - 25 1 ml IM VentroglutealOO
12 months to 5
years
Vastus lateralis
2 ml IM
Deltoid
1 ml IM


IM
IM
IM
IM

3 ml
1 ml
3 ml
CHILDREN
1" - 1" 20 - 25
22 - 25
20 - 25
Ventrogluteal OO
5 years to 18
years
1" Deltoid O
1 - 1" Vastus lateralis
1 - 1 20 - 25 3 ml DorsoglutealO


ADULTS
19 years

1 - 1"



20 - 22
20 - 22
20 - 22
20 - 22

Ventrogluteal OO
Deltoid O
Vastus lateralis

IM
IM
IM
IM

4 ml
2 ml
5 ml
DorsoglutealO

5 ml
O The ventrogluteal site can be used in children >7 months of age.
O The ventrogluteal muscle is the preferred site for administration of all immune
globulin preparations to children and adults.
O Alternate sites for the administration of immune globulin preparations are the deltoid and
vastus lateralis; in exceptional circumstances, the dorsogluteal site may be used.
O The deltoid is not to be used for the administration of RabIg. Its use should be reserved for
the administration of rabies vaccine.
O Use of the dorsogluteal site is only recommended when the ventrogluteal and vastus
lateralis sites have had maximum volumes of an immune globulin preparation injected and
an additional volume still needs to be administered. This is due to the possibility of sciatic
nerve injuries when the injection is done in the dorsogluteal site.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 29


Immune Globulin Preparations or Blood: Timing Intervals For Vaccines Containing Live
asles, Mumps, Rubella, or Varicella Virus
Ig preparations and/or blood products can interfere with the immune response of a measles,
mumps, rubella or varicella-containing vaccine. For measles (routinely given as MMR) and
varicella vaccines, the recommended interval between Ig administration and subsequent
vaccination varies from 3 to >11 months, depending on the specific product and dose given (see
table below).
If the Ig preparation or blood product is given > 14 days after MMR or varicella vaccine, the
immunization does not need to be repeated.
If the interval between administration of MMR or varicella vaccine and subsequent
administration of an Ig preparation or blood product is <14 days, immunization should be
repeated at the interval indicated in the table below.


Product O

Dose



Indication Interval
(Months)
Immune Globulin (Ig) Hepatitis A:
Contact Prophylaxis
International travel
Measles prophylaxis:
Healthy contact
Immunocompromised contact

0.02 ml/kg 3
0.06 ml/kg

0.25 ml/kg
3

5
0.5 ml/kg 6
BabyBig Infant botulism 100 mg/kg 5

Intravenous Immune
Globulin (IGIV)

Treatment of antibody
deficiency



Treatment of Idiopathic
Thrombocytopenic Purpura or
Kawasaki Disease

160 mg/kg
320 mg/kg
640 mg/kg
>640 -1280
mg/kg

1280 mg/kg

7
8
9
10


11

0.06 ml/kg

Hepatitis B Immune Globulin
(HBIg)
Hepatitis B prophylaxis 3

Human Rabies Immune
Globulin (RabIg)

Rabies prophylaxis

20 IU/kg

4

Tetanus Immune Globulin
(TIg)

Tetanus prophylaxis

250 units

3


V

aricella prophylaxis

125 units/10 kg
max dose is
625 units

Varicella Zoster Immune
Globulin (Human) VarIg
5
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 30



Immune Globulin Preparations or Blood: Timing Intervals for Vaccines Containing Live
Measles, Mumps, Rubella, or Varicella Virus

Product

Indication

Interval Dose
(Months)

Washed red blood cells

10 ml/kg IV

0

Reconstituted red blood
cells



10 ml/kg IV

3

Whole Blood (Hct 36%)



10 ml/kg IV

6



Packed red blood cells 10 ml/kg IV

6

Plasma/platelet products



10 ml/kg IV

7

Rh immune globulin (RhIg)

Post-partum for Rh negative
women

150 to 300
micrograms

2 OO

RSV Ab

Prevention of RSV disease
in children < 24 mos with
bronchopulmonary
dysplagia or history of
premature birth etc.

RSV Ab is routinely
given once per
month through the
RSV season.
(Palivizumab)
(monoclonal antibody)

0 O
O Provide a written record to a client who receives any immune globulin product.
O Rubella-susceptible women who receive RhIg post-partum should be given MMR vaccine
at the same time as RhIg (as soon as possible following delivery) and tested 2 months
later to determine rubella immunity. If the woman is not immune, administer another dose
of MMR vaccine. Alternately, if follow-up can be ensured, administer MMR vaccine 2
months after delivery.
O Varicella-susceptible women who receive RhIg post-partum should be given the first dose of
varicella vaccine 2 months after delivery.

O Monoclonal antibody preparation (Palivizumab) does not interfere with the immune
response to vaccines.


Communicable Disease Control
Immunization Program
Section VII Biological Products
September 2010
Page 31


Seasonal Trivalent Influenza Vaccine (Inactivated Split Virion or Subunit)
Recommended and provided free to the following groups:(1) People at high risk:
People 65 years of age
People of any age who are residents of long-term care facilities
Adults (including pregnant women) and children with the following chronic health conditions:
- Cardiac or pulmonary disorders (e.g., bronchopulmonary dysplasia, cystic fibrosis, asthma)
- Diabetes and other metabolic diseases
- Cancer; immunodeficiency (including human immunodeficiency virus [HIV] infection);
immunosuppression due to underlying disease or therapy (e.g., severe rheumatoid arthritis requiring
immunosuppressive therapies)
- Chronic kidney disease
- Chronic liver disease, including hepatitis C
- Anemia and hemoglobinopathy
- Conditions that compromise the management of respiratory secretions and are associated with an
increased risk of aspiration (e.g., cognitive dysfunction, spinal cord injury, seizure disorder, and
neuromuscular disorders)
Children and adolescents (age 6 months to 18 years) with conditions treated for long periods with
acetylsalicylic acid
Adults who are morbidly obese (BMI 40)
Aboriginal peoples (on and off reserve) for the 2010 2011 influenza season
Healthy children age 6 to 23 months
Pregnant women who will be in their 3
rd
trimester during the influenza season (typically spanning
November to April) O
Inmates of provincial correctional institutions
People working with live poultry (Immunization may reduce the potential for human-avian reassortment
of genes should such workers become coinfected with human and avian influenza.)

(2) People capable of transmitting influenza to those at high risk:
Healthcare workers (HCW) and other personnel who have significant contact with people in the high-risk
groups previously described O The HCW groups include independent health care practitioners and their
staff in community settings.
Household contacts (including children) of people at high risk whether or not those high-risk people have
been immunized
Those who provide care or service in potential outbreak settings housing high risk persons (e.g., crew on
ships)
Household contacts of children age 0 to 23 months
Those providing regular child care to children age 0 to 23 months, whether in or out of the home

(3) People who provide essential community services:
First responders: police, fire fighters, ambulance
Corrections Officers
O Large cohort studies of health databases have demonstrated that there is no association between childhood
vaccination with thimerosal-containing vaccines and neurodevelopmental outcomes, including autistic-spectrum disorders.
Similar large-scale studies have not addressed prenatal exposure to thimerosal-containing vaccines in pregnancy. As a
precautionary measure, thimerosal-reduced VAXIGRIP has been made specifically available for pregnant women in
British Columbia. Where VAXIGRIP is not available, FLUVIRAL should be given if indicated.

O This includes persons carrying out paid or unpaid work in a health care facility; including persons who volunteer or
undergo training in a health care facility for any period of time between November and April.

Communicable Disease Control
Immunization Program
Section VII Biological Products
October 22, 2010
Page 32


INDICATIONS See Seasonal Trivalent Influenza Vaccine
Age Group Dosage No. Of Doses
6-35 months 0.25 ml IM 1 or 2 O
3-8 years 0.5 ml IM 1 or 2 O
DOSE BY AGE GROUP
9 years 0.5 ml IM 1
REVACCINATIONS Yearly
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of any type of
influenza vaccine
2. History of anaphylactic reaction to any component of
FLUVIRAL
3. History of anaphylactic reaction to eggs
4. History of Guillain-Barr syndrome (GBS) within 8 weeks of
receipt of a previous dose of influenza vaccine
5. Infants less than 6 months of age
PRECAUTIONS
Severe oculo-respiratory syndrome (ORS)O after a previous dose of
influenza vaccine.
VACCINE
COMPONENTS
Egg protein, formaldehyde, thimerosal (50 g per 0.5 mL, = 0.01% w/v),
sodium deoxycholate
ADVERSE EVENTS Transient injection site reactions
Fever, malaise, myalgia, and fatigue 6-12 hours following
vaccination and lasting ~1 - 2 days, especially in individuals
receiving influenza vaccine for the 1
st
time
About 1 in 20 people may have cough, sore throat, hoarseness
or red eyes, sometimes called oculo-respiratory syndrome.
Generalized itching may occur, but is uncommon.
SPECIAL
CONSIDERATIONS
Discard multi-dose vials 28 days after first entry.
O Children under 9 years of age who have not previously received seasonal trivalent influenza vaccine
require 2 doses given 4 weeks apart. This applies regardless of whether the child received monovalent
pH1N1 vaccine in 2009-10. If the child has received one or more doses of seasonal trivalent influenza
vaccine in any previous season, only a single dose is required this season.
OORS consists of bilateral red eyes or facial swelling or respiratory symptoms such as cough, wheeze,
sore throat, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, or sore throat beginning
within 24 hours of vaccination. Most people who have had ORS after a previous dose of influenza vaccine
do not experience it again. About 5 - 34% experience another episode but it is usually milder. If a client
has received influenza vaccine without difficulty following an episode of severe ORS, they may be
revaccinated with the vaccine prepared for this season.
Severe symptoms of ORS include wheezing, chest tightness/discomfort, difficulty breathing or severe
throat constriction/difficulty swallowing. When a client has had severe ORS following influenza vaccine and
not received influenza vaccine since, this is considered to be a precaution to future receipt of influenza
vaccine. Such individuals who wish to receive influenza vaccine should consult with their primary care
physician and Medical Health Officer for an expert review to distinguish between severe ORS and any
anaphylaxis risk.
Consult the National Advisory Committee on Immunization Statement on Influenza Vaccination for the
Influenza Vaccine (Inactivated Split Virion) (FLUVIRAL)
Supplier: GlaxoSmithKline Inc.
Communicable Disease Control
Immunization Program
Section VII Biological Products
October 22, 2010
Page 32


current season.
Communicable Disease Control
Immunization Program
Section VII Biological Products
October 22, 2010
Page 33


INDICATIONS See Seasonal Trivalent Influenza Vaccine Preferential use in
pregnant women.
Age Group Dosage No. of Doses
6-35 months 0.25 ml IM 1 or 2 O
3-8 years 0.5 ml IM 1 or 2 O
DOSE BY AGE GROUP
0.5 ml IM 1 9 years
Yearly REVACCINATIONS
1. History of anaphylactic reaction to a previous dose of any type of
influenza vaccine
CONTRAINDICATIONS
2. History of anaphylactic reaction to any component of VAXIGRIP
3. History of anaphylactic reaction to eggs
4. History of Guillain-Barr syndrome (GBS) within 8 weeks of
receipt of a previous dose of influenza vaccine
5. Infants less than 6 months of age
Severe oculo-respiratory syndrome (ORS) O after previous receipt of
an influenza vaccine.
PRECAUTIONS
VACCINE COMPONENTS
Egg protein, neomycin, formaldehyde, thimerosal (2 g per 0.5 mL, =
0.0004% w/v), sodium phosphate, sucrose, TritonX-100
ADVERSE EVENTS Transient injection site reactions
Fever, malaise, myalgia, and fatigue 6-12 hours following
vaccination and lasting 1-2 days, especially in individuals
receiving influenza vaccine for the 1st time
About 1 in 20 people may have cough, sore throat, hoarseness or
red eyes, sometimes called oculo-respiratory syndrome.
Generalized itching may occur, but is uncommon.
SPECIAL
CONSIDERATIONS
Discard multi-dose vials 7 days after first entry. Use VAXIGRIP in
other eligible groups in order to use up remaining doses in a vial post-
puncture.
O Children under 9 years of age who have not previously received seasonal trivalent influenza vaccine
require 2 doses given 4 weeks apart. This applies regardless of whether the child received monovalent
pH1N1 vaccine in 2009-10. If the child has received one or more doses of seasonal trivalent influenza
vaccine in any previous season, only a single dose is required this season.
O ORS consists of bilateral red eyes or facial swelling or respiratory symptoms such as cough, wheeze, sore
throat, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, or sore throat beginning within
24 hours of vaccination. Most people who have had ORS after a previous dose of influenza vaccine do not
experience it again. About 5-34% experience another episode but it is usually milder. If a client has received
influenza vaccine without difficulty following an episode of severe ORS, they may be revaccinated with the
vaccine prepared for this season. Severe symptoms of ORS include wheezing, chest tightness/discomfort,
difficulty breathing or severe throat constriction/difficulty swallowing. When a client has had severe ORS
following influenza vaccine and not received influenza vaccine since, this is considered to be a precaution to
future receipt of influenza vaccine. Such individuals who wish to receive influenza vaccine should consult with
their primary care physician and Medical Health Officer for an expert review to distinguish between severe
ORS and any anaphylaxis risk. Consult the National Advisory Committee on Immunization Statement on
Influenza Vaccination for the current season.
Influenza Vaccine (Inactivated Split Virion) (Thimerosal-reduced VAXIGRIP)
Supplier: Sanofi Pasteur Limited
Communicable Disease Control
Immunization Program
Section VII Biological Products
October 22, 2010
Page 34


INDICATIONS Individuals 18 years of age that have a history of anaphylactic
reaction to thimerosal
DOSAGE 0.5 ml IM O
REVACCINATION Yearly
VACCINE
COMPONENTS
Eggs, chicken protein, formaldehyde, cetyltrimethylammonium
bromide, polysorbate 80, gentamicin, potassium chloride, potassium
dihydrogen phosphate, disodium phosphate dihydrate, calcium
chloride, and magnesium chloride hexahydrate
CONTRAINDICATIONS
Influenza Vaccine (Inactivated Subunit) (INFLUVAC)
Supplier: Solvay Pharma Inc
1. History of anaphylactic reaction to a previous dose of any type
of influenza vaccine
2. History of anaphylactic reaction to any component of
INFLUVAC
3. History of anaphylactic reaction to eggs
4. History of Guillain-Barr syndrome (GBS) within 8 weeks of
receipt of a previous dose of influenza vaccine
5. Individuals less than 18 years of age

Severe oculo-respiratory syndrome (ORS) O after previous receipt
of an influenza vaccine.
PRECAUTIONS
ADVERSE EVENTS

Transient injection site reactions
Headache, fever, increased sweating, malaise, insomnia,
shivering, myalgia, arthralgia, and fatigue, especially in
individuals receiving vaccine for the 1
st
time
About 1 in 20 people may have cough, sore throat, hoarseness
or red eyes, sometimes called oculo-respiratory syndrome.
Generalized itching may occur, but is uncommon.
O INFLUVAC is a clear to slightly opalescent liquid supplied in a pre-filled syringe: thimerosal- and
preservative-free. Shake syringe well just prior to vaccine administration.
O ORS consists of bilateral red eyes or facial swelling or respiratory symptoms such as cough, wheeze,
sore throat, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, or sore throat
beginning within 24 hours of vaccination. Most people who have had ORS after a previous dose of
influenza vaccine do not experience it again. About 5 - 34% experience another episode but it is
usually milder. If a client has received influenza vaccine without difficulty following an episode of
severe ORS, they may be revaccinated with the vaccine prepared for this season.
Severe symptoms of ORS include wheezing, chest tightness/discomfort, difficulty breathing or
severe throat constriction/difficulty swallowing. When a client has had severe ORS following
influenza vaccine and not received influenza vaccine since, this is considered to be a precaution to
future receipt of influenza vaccine. Such individuals who wish to receive influenza vaccine should
consult with their primary care physician and Medical Health Officer for an expert review to
distinguish between severe ORS and any anaphylaxis risk.
Consult the National Advisory Committee on Immunization Statement on Influenza Vaccination for
the current season.


Communicable Disease Control
Immunization Program
Section VII Biological Products
September 2010
Page 34a

Influenza Vaccine (Inactivated Subunit) (AGRIFLU)
Supplier: Novartis Vaccines and Diagnostics, Inc.
AGE INDICATIONS Individuals 6 months of age and older
ROUTE IM
SPECIAL
ONSIDERATIONS

The National Advisory Committee on Immunization has not yet issued a
statement on the recommended uses or contraindications for this product. In
the interim, consult the product monograph available at:
http://www.ask.novartispharma.ca/download.htm?res=agriflu_scrip_e.pdf&resTitleId=
240


Communicable Disease Control
Immunization Program
Section VII Biological Products
September 2010
Page 34b

Influenza Vaccine (Live, Attenuated) (FLUMIST)
AGE INDICATIONS Individuals 2-59 years of age
Supplier: AstraZeneca Canada
Intranasal ROUTE
SPECIAL
CONSIDERATIONS
The National Advisory Committee on Immunization has not yet issued a
statement on the recommended uses or contraindications for this product. In
the interim, consult:
1. The product monograph available at:
http://www.astrazeneca.ca/documents/ProductPortfolio/FLUMIST_PM_en.pdf

and/or

2. The Recommendations of the United States Advisory Committee on
Immunization Practices (ACIP) for the 2010-11 season available at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5908a1.htm?s_cid=rr5908a1_w
Note especially Table 1 of that statement. Note also that in the United
States upper age indication for this product is 49 years rather than 59 years
as for Canada.



Communicable Disease Control
Immunization Program
Section VII Biological Products
September 2010
Page 34c

Influenza Vaccine (Inactivated Split Virion) (INTANZA)
Age Group Dosage
Supplier: Sanofi Pasteur Limited
18-59 years of age 9 g
AGE INDICATIONS
Adults 60 years of age and older 15 g
ROUTE Intradermal injection
SPECIAL
CONSIDERATIONS
The National Advisory Committee on Immunization has not yet issued a
statement on the recommended uses or contraindications for this product.
In the interim, consult the product monograph available at:
http://www.sanofipasteur.ca/sanofi-pasteur2/sp-
media/SP_CA/EN/75/1215/415%20416%20INTANZA%20R0-0510%20En.pdf


Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 35

Measles/Mumps/Rubella Vaccine (Live Attenuated Viral) MMRII & Priorix
Suppliers: Merck Frosst, MMRII ; GlaxoSmithKline, Priorix
INDICATIONS INITIAL SERIES
(1) Infants at 12 months of age



(2) Adult HSCT recipients



(3) Infants from 6 months but <12 months of age, if
travelling to endemic areas



(4) All individuals who require protection against
measles, mumps, OR rubella OO O
(1) Dose 1: 0.5 ml SC O
Dose 2: 0.5 ml SC at
18 months of ageO O

(2) Dose 1: 0.5 ml SC OO
Dose 2: 0.5 ml SC
(6 12 months later) OO

(3) One dose of 0.5 ml SCO
(upon return, give 2
additional doses at routine
times)

(4) Dose 1: 0.5 ml SC O
Dose 2: 0.5 ml SC O
(1 month later)
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of a measles/mumps/rubella-containing
vaccine, to any component of MMRII or Priorix, or to latex when administering Priorix
with the pre-filled syringe (latex is present in the pre-filled syringe of diluent for Priorix).
2. Consult the appropriate physician (i.e., either the primary care physician most familiar with the
clients current medical status or a medical specialist) and obtain a written referral regarding
the appropriateness of MMR vaccine administration to persons whose immune status may be
suppressed as the result of disease or therapy. Refer to BC Communicable Disease Control
Manual Chapter 2, Section III, Subsection 1.4. Immunization With Live Vaccines and use
Referral Form for MMR Vaccination.
3. Pregnancy. Counsel female recipients to avoid pregnancy for 1 month following
immunization. Risk is theoretical and not observed. Inadvertent immunization during
pregnancy is not considered a medical indication for therapeutic abortion.
4. Recent administration of an immune globulin preparation or blood product (see Immune
Globulin Preparations or Blood: Timing Intervals For Vaccines Containing Live Measles,
Mumps, Rubella, or Varicella Virus)
5. Physician-diagnosed significant thrombocytopenia after first dose of a MMR vaccine.
6. For high risk/immunocompromised clients only: separate the administration of MMR and
varicella vaccine by least 4 weeks.
7. Family history of congenital immunodeficiency. See BC Communicable Disease Control
Manual, Chapter 2, Section II B 2.0 ASSESSMENT FOR CONTRAINDICATIONS AND
PRECAUTIONS

VACCINE COMPONENTS Components of MMRII are neomycin, sorbitol, sucrose, sodium
phosphate, human albumin, fetal bovine serum, and hydrolyzed
gelatin. Components of Priorix are neomycin sulphate, lactose,
amino acids, human albumin, mannitol, and sorbitol.

Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 36


Measles/Mumps/Rubella Vaccine (Live Attenuated Viral) MMRII & Priorix
Suppliers: Merck Frosst, MMRII ; GlaxoSmithKline, Priorix
PRECAUTIONS Measles/mumps/rubella immunization should be given on the same day
or delayed until 4 weeks after administration of any other live vaccine.
Anti-Rho (D) immune globulin may interfere with response to the rubella
component of the vaccine. Rubella-susceptible women who receive anti-
Rho(D) immune globulin post-partum should either be given MMR
vaccine at the same time and tested 2 months later for rubella immunity,
or should be immunized with MMR vaccine 2 months post-partum, with
follow-up ensured.
Do TB skin testing on the same day as MMR immunization, or delay TB
skin testing for 4 weeks.
ADVERSE EVENTS Local - Tenderness, redness, swelling, induration, wheal and flare reaction,
urticaria
Systemic Moderate fever, rash, malaise, headache, and nausea, myalgia,
and paraesthesia; thrombocytopenia; encephalitis. Acute transient arthritis or
arthralgia is uncommon in children, but frequency and severity increases with
age. 25% of post-pubertal females may experience arthralgia, and 10% may
have arthritis-like signs and symptoms.
SPECIAL
CONSIDERATIONS
Consult the appropriate physician (i.e., either the primary care physician most
familiar with the clients current medical status or a medical specialist) and
obtain a written referral (Use Referral Form for MMR Vaccination) regarding
the appropriateness of MMR vaccine administration to persons whose
immune status may be suppressed as the result of disease or therapy
(e.g., chronic renal disease / dialysis; HIV/AIDs (if no significant
compromise); solid organ transplant candidate; hyposplenia/asplenia; 3
months after being cured of a malignant disease and the end of
immunosuppressive treatment; and high doses of oral corticosteroid therapy)
O Administer the entire volume of reconstituted product, which may be 0.5 0.7 ml
O 2
nd
dose must be given at least 1 month after 1st dose. Second dose is provided for protection against
measles and, for some age groups, mumps.
O Wait at least 24 months after ablative therapy before administering MMR and then only if the recipient is
deemed to be immunocompetent by the transplant specialist. MMR should not be given to those with chronic
graft-versus-host disease (GVHD) or those taking immunosuppressive therapy for chronic GVHD.
O Those born prior to 1957 are considered to have acquired natural immunity to measles, mumps, and rubella.
O For protection against:
measles: 2 doses of a measles - containing vaccine are recommended for all individuals born on or after
January 1, 1957 who do not have a history of lab confirmed measles infection, lab evidence of immunity,
or documentation of 2 doses of a live measles-containing vaccine at 12 months of age and given at least
4 weeks apart.
mumps: 2 doses of a mumps containing vaccine are recommended for all individuals born on or after
January 1, 1970 ; one dose is recommended for all individuals born January 1,1957 to December 31,
1969 who do not have evidence of immunity to mumps disease
rubella: One dose is recommended for all individuals born on or after January 1, 1957 who have not
received at least 1 dose of a rubella-containing vaccine or who do not have serologic evidence of rubella
immunity. One dose is considered evidence of immunity to rubella.
O See Referral Form for MMR Vaccination for list of individuals whose immune status may be suppressed and
for whom the appropriate physician (i.e., either the primary care physician most familiar with the clients current
medical status or a medical specialist) needs to provide a written referral.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 37



Meningococcal C Conjugate (MCC) Vaccine (Meningitec)
Supplier: Wyeth
INDICATIONS INITIAL SERIES O
(1) Children born on or after July 1, 2002
who either have not been previously
vaccinated or who received their last
dose of any MCC vaccine when they
were less than 12 months of age

(2) Adults born on or after January 1, 1988


(3) Close contacts (< 2 years of age) of a
case of invasive meningococcal group
C disease that meet the public health
criteria for chemoprophylaxis O O who
have NOT been previously vaccinated
with MCC vaccine





(4) Medically high risk O children 2 10
years of age who have NOT been
previously vaccinated with MCC
vaccine

(5) Children that received Menactra prior
to 11 years of age, and are age-eligible
for MCC vaccine

(1) One dose: 0.5 ml IM at 12 months of age O





(2) One dose: 0.5 ml IM O


(3) Age at presentation:
2 months to <12 months of age:
Dose 1: 0.5 ml IM
Dose 2: 0.5 ml IM at least 2 months after 1st dose
Dose 3: 0.5 ml IM at 12 months of age (at least 2
months after 2nd dose)

12 months of age (any MCC vaccine may be
used):
One dose: 0.5 ml IM O

(4) One dose: 0.5 ml IM O O
NOTE: If Meningitec is given for the 1
st
infant
dose, continue the series with MeningitecO

(5) One dose: 0.5 ml IM O
CONTRAINDICATIONS History of anaphylactic reaction to a previous dose
of any meningococcal vaccine or to any component
of Meningitec
VACCINE COMPONENTS Aluminum phosphate, diphtheria CRM
197
protein.
ADVERSE EVENTS All: Redness, swelling and pain at injection site
In adolescents and adults: headache, myalgia,
and fever.
In younger children: irritability, crying, change
in appetite, diarrhea, and fever
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 38



Meningococcal C Conjugate (MCC) Vaccine (Meningitec)
Supplier: Wyeth

O There must be an interval of at least 6 months since the prior administration of a
meningococcal polysaccharide vaccine and the administration of Meningitec.
O Meningococcal C conjugate vaccines are interchangeable for those 12 months of age
O Administer concurrently with chemoprophylaxis or as soon as possible.
O A MCC vaccine is preferred in this situation as it provides longer duration of protection
and induction of immunologic memory than does a meningococcal C-containing
polysaccharide vaccine and is less expensive than Menactra.
O See Meningococcal Quadrivalent Conjugate Vaccine (Menactra) for list of medical
indications. Children < 2 yrs old: give MCC 1
st
, followed by Menactra after 2
nd
birthday.
Children 2 yrs to 10 years of age (inclusive): give Menactra first, followed by MCC
vaccine one month later.
O Meningitec infant series is 2 doses, given at least 2 months apart, followed by a
booster dose given at 12 months of age.









Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 39


Meningococcal C Conjugate (MCC) Vaccine (Neis Vac-C)
Supplier: GlaxoSmithKline
INDICATIONS INITIAL SERIESO
(1) Two-dose program for infants born on
or after April 1, 2005




(2) Children born on or after July 1, 2002
who either have not been previously
vaccinated or who received their last
dose of any MCC vaccine when they
were less than 12 months of age

(3) Medically high risk children 2 months
to < 12 months of ageO

(4) Close contacts of a case of invasive
meningococcal group C disease that
meet the public health criteria for
chemoprophylaxisOO who have NOT
been previously vaccinated with MCC
vaccine

(5) Medically high riskO children 2 10
years of age who have NOT been
previously vaccinated with any MCC
vaccine

(6) Grade 6 students O

(7) Adults born on or after January 1,
1988

(1) Dose 1: 0.5 ml IM at 2 months of age or age at
presentation. (When age of presentation is 12
months, one dose only is required.)
Dose 2: 0.5 ml IM at 12 months of age (at
least 2 months after 1
st
dose)OO

(2) One dose: 0.5 ml IM at 12 months of age O




(3) & (4) Age at presentation:
2 months to <12 months of age:
Dose 1: 0.5 ml IM
Dose 2: 0.5 ml IM at least 2 months after 1st dose
Dose 3: 0.5 ml IM at 12 months of age (at least 2
months after 2nd dose)

12 months of age (any MCC vaccine may be
used):
One dose: 0.5 ml IM O

(5) One dose: 0.5 ml IM O





(6) One dose: 0.5 ml IM O (at least 8 weeks
since a previous MCC vaccine dose)

(7) One dose: 0.5 ml IM O



CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose
of any meningococcal vaccine or to any
component of Neis Vac-C vaccine.
VACCINE COMPONENTS Aluminum hydroxide, tetanus toxoid
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 40



Meningococcal C Conjugate (MCC) Vaccine (Neis Vac-C)
Supplier: GlaxoSmithKline
ADVERSE EVENTS All: redness, swelling and pain at injection site;
headache, fever
Infants and toddlers: crying, irritability,
drowsiness, somnolence/impaired sleeping
Infants: vomiting/nausea/diarrhea/loss of appetite
SPECIAL CONSIDERATIONS Upon storage, a white deposit and clear
supernatant can be observed. Shake the vaccine
well in order to obtain a homogenous suspension.
O There must be an interval of at least 6 months since the prior administration of a
meningococcal polysaccharide vaccine and the administration of Neis Vac-C.
O Meningococcal C conjugate vaccines are interchangeable for those 12 months of age.
O If an infant has a history of receiving their last dose before 12 months of age, give an
additional dose at 12 months of age.
O Administer concurrently with chemoprophylaxis or as soon as possible.
O A MCC vaccine is preferred in this situation as it provides longer duration of protection and
induction of immunologic memory than does a meningococcal C-containing polysaccharide
vaccine and is less expensive than Menactra.
O See Meningococcal Quadrivalent Conjugate Vaccine (Menactra) for list of medical
indications. Medically high risk children < 2 yrs old: give MCC 1st, followed by Menactra
after 2nd birthday. Medically high risk children 2 yrs to 10 years of age (inclusive): give
Menactra first, followed by MCC vaccine one month later.

O A grade 6 student is considered up-to-date for MCC vaccine if they have a dose of MCC
vaccine on or after their 10th birthday. The interval between MCC doses is a minimum of 8
weeks.








Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 41


Meningococcal Quadrivalent Conjugate Vaccine (Menactra)
(Groups A, C, Y, W-135)
Supplier: sanofi pasteur
INDICATIONS
(1) Provided free to medically high risk individuals 2 years of age:
Functional or anatomic asplenia O
Congenital immunodeficiency states (e.g., complement, properdin or factor D deficiency, primary antibody
deficiencies)
Hematopoietic Stem Cell Transplant
Solid organ transplant (candidate or recipient)
Islet cell transplant (candidate or recipient)

Refer to BC Communicable Disease Control Manual, Chapter 2, Section III for more information on specific
medical conditions.

Note: Children 2 10 years of age (inclusive) with a medical indication (as specified above) who have NOT
been previously vaccinated with MCC vaccine:
Administer Menactra followed by MCC vaccine one month later O

(2) Close contacts ( 2 years of age) of a case of invasive meningococcal disease (serogroups A, Y, or
W-135) that meet the public health criteria for chemoprophylaxis OO

(3) Individuals who have previously been vaccinated with Menomune and for whom there is a need
for re-vaccination due to:
high risk medical status
continuing outbreak exposure, or
expected ongoing exposure during travel

Administer Menactra as follows:
First dose of Menomune Immunize with Menactra when 2 years of age
(polysaccharide A/C/Y/W-135) received at: and it is:
3 12 months of age 6 months since last dose of Menomune
13 23 months of age 1 year since last dose of Menomune
2 5 years of age 2 years since last dose of Menomune
6 years of age 5 years since last dose of Menomune

(4) Recommended, but not provided free to:
research, industrial, and clinical laboratory personnel who are routinely exposed to N. meningitidis
military recruits
travellers for whom meningococcal vaccine is indicated



Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 42






Meningococcal Quadrivalent Conjugate Vaccine (Menactra)
(Groups A, C, Y, W-135)
Supplier: sanofi pasteur
DOSE
Persons 2 years of age: One dose: 0.5 ml IM
REINFORCEMENTS
Medically high risk persons: (dose: 0.5 ml IM)
First dose received at 7 years of age: give 5 years after 1st dose
First dose received at ages 2 6 years: give 3 years after 1st dose
Thereafter, re-immunize every 5 years as long as medical condition exists.
SPECIAL CONSIDERATIONS
If a Grade 6 child received Menactra when they were 2 10 years of age, and have not
received a dose of MCC vaccine on or after their 10
th
birthday, administer MCC vaccine.
CONTRAINDICATIONS
(1) Known history of Guillain-Barr syndrome (GBS)O.
(2) History of anaphylactic reaction to a previous dose of any meningococcal or diphtheria-
containing vaccine, to any component of Menactra or to latex (if using the vial
presentation). The pre-filled syringe presentation does not contain latex.
VACCINE COMPONENTS
Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic.
ADVERSE EVENTS
Local pain, redness, swelling, headache, malaise, chills, fever.
O Give vaccine at least 14 days prior to elective splenectomy, or if not possible, 14 or more
days post-splenectomy. When there is concern that the patient may not present later for
immunization, give vaccine before discharge.
O The recommended interval between the administration of any meningococcal C conjugate
vaccine and Menactra is one month (regardless of which vaccine was given first).
O Administer vaccine concurrently with chemoprophylaxis or as soon as possible.
O Any prior history of GBS is a relative contraindication to Menactra vaccine. Immunization
may be considered if the benefit of vaccination outweighs the potential risk of recurrence of
GBS if the vaccine is given. For more information, see BCCDC Communicable Disease
Control Manual, Chapter 2, Section III Subsection 2.8.2 Those who develop symptoms of a
new neurologic condition at any time after immunization.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 43


Meningococcal Quadrivalent Polysaccharide Vaccine (Menomune)
(Groups A, C, Y, W-135)
Supplier: sanofi pasteur

INDICATIONSO (1) Provided free to close contacts ( 3 23 months of age) of a case
of meningococcal group A disease that meet the public health criteria
for chemoprophylaxis OO
(2) Provided free to children ( 3 23 months of age) for control of
outbreaks of meningococcal group A disease (following consultation
with BCCDC, Epidemiology Services)
(3) Provided free to close contacts 2 years of age of a case of
meningococcal group A, Y or W 135 disease that meet the public
health criteria for chemoprophylaxis OO
INITIAL SERIES O Children 3 - 23 months of age:
Dose 1: 0.5 ml SC
Dose 2: 0.5 ml SC (3 months later)
Persons 2 years of age: One dose: 0.5 ml SC
REVACCINATION
For protection against Group A meningoccocal disease, re-immunize children 3 23
months of age when there is continuing outbreak exposure or expected ongoing exposure during
travel.
First dose of Menomune Reimmunize with Menomune when:

3 12 months 6 months since last dose of Menomune
13 23 months of age 1 year since last dose of Menomune

OFor protection against Group A meningoccocal disease, administer Menactra when child is 2
years of age if there is continuing outbreak exposure or expected ongoing exposure during travel .
SPECIAL
CONSIDERATIONS
Once reconstituted, single dose vaccine must be used within 24 hours
CONTRAINDICATIONS
History of anaphylactic reaction to a previous dose of any
meningococcal vaccine, to any component of Menomune or to latex.
Thimerosal and lactose. VACCINE
COMPONENTS
ADVERSE EVENTS Local pain, redness, swelling, headache, malaise, chills, fever.
O Children less than 2 years of age are not eligible for Menactra as it has not been approved
for use in that age group. Use at age 2 as indicated in the above situation.
O Administer vaccine concurrently with chemoprophylaxis or as soon as possible.
O There must be an interval of at least 2 weeks since the prior administration of a MCC vaccine
and the administration of Menomune.

O If child has been previously immunized with Menomune and it is within the time period
before re-vaccination is due, there is no need to administer vaccine.

Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 44


Pneumococcal Conjugate Vaccine (Prevnar

13)
Supplier: Wyeth, a Pfizer Company
INDICATIONS INITIAL SERIES
(1) Healthy infants and children 2 to 59 months of age to
start or complete a pneumococcal conjugate vaccine
series





(2) Children 2 months to 59 months of age who are at
high risk of pneumococcal disease due to: OOO
Sickle cell disease and other hemoglobinopathies
Immunosuppression related to disease [e.g., malignant
neoplasm (including leukemia and lymphoma); HIV;
multiple myeloma] or therapy (e.g., high dose, systemic
steroids or severe rheumatoid arthritis requiring
immunosuppressive therapy)
Congenital immunodeficiencies involving any part of the
immune system, including B-lymphocyte (humoral)
immunity, T-lymphocyte (cell-mediated) immunity,
complement system (properdin or factor D deficiencies)
or phagocytic function.
Receipt of hematopoietic stem cell transplant (HSCT)
Solid organ or islet cell transplant (candidate or recipient)
Chronic heart or lung disease (except asthma, unless
management involves ongoing high dose oral
corticosteroid therapy)
Chronic liver disease including cirrhosis, chronic hepatitis
B, chronic hepatitis C
Chronic kidney disease
Diabetes, cystic fibrosis or chronic CSF leak
Chronic neurological conditions that may impair
clearance of oral secretions
Cochlear implant (candidate or recipient)
Anatomic or functional asplenia (children up to and
including 16 years of age) O

(3) High risk children to 59 months of age and
asplenics 16 years of age who have completed a
PVC 7 or PCV 10 vaccine seriesO
(1) Healthy children:

Dose 1: 2 months of age: 0.5 ml IM
Dose 2: 4 months of age: 0.5 ml IM
Dose 3: 12 months of age: 0.5 ml IM
(at least 8 weeks after second dose).


(2) Children medically at high risk:

Dose 1: 2 months of age: 0.5 ml IM
Dose 2: 4 months of age: 0.5 ml IM
Dose 3: 6 months of age: 0.5 ml IM
Dose 4: 12 months of age: 0.5 ml IMO
(at least 8 weeks after third dose)






















(3) One dose 0.5 ml IM at least 8
weeks after a previous PCV 7 or PCV
10 dose
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 44a


Pneumococcal Conjugate Vaccine (Prevnar

13)
Supplier: Wyeth, a Pfizer Company
CONTRAINDICATIONS: History of an anaphylactic reaction to a previous dose of any pneumococcal
vaccine, or to any component of Prevnar

13.
VACCINE COMPONENTS: Diphtheria toxoid, succinic acid, polysorbate 80, aluminum phosphate
ADVERSE EVENTS: Redness, swelling, tenderness at injection site; fever, irritability, drowsiness,
restless sleep, decreased appetite, vomiting, diarrhea
O High risk children should receive one dose of pneumococcal polysaccharide vaccine at 2 years
of age, and at least 8 weeks after the final dose of pneumococcal conjugate vaccine.

O Unimmunized asplenics identified at 5-16 years of age require two doses of vaccine, 8 weeks
apart. Give vaccine at least 14 days prior to elective splenectomy, or, if not possible 14 days
post-splenectomy. If there is concern that the patient may not present later for immunization,
give at hospital discharge.

O Give vaccine before initiation of immunosuppression therapy, and early in the course of HIV
infection.

O A complete series for a high risk child is:
three (PVC7 or PCV10) primary doses given at appropriate intervals and a 4
th
dose given on
or after 12 months of age and at least 8 weeks after previous dose, or
a delayed or interrupted schedule that has been completed at a later age according to the
information in table Completing a Pneumococcal Conjugate Vaccine Series.

Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 45


Completing a Pneumococcal Conjugate Vaccine Series
Completion of series
requires
Age at presentation
for immunization

History of prior doses of
PCV7, PCV10 or PCV13
given

Healthy
Infant

High Risk
Infant
O O

Booster dose
Healthy and
High Risk O
0 doses 2 dosesO 3 dosesO
1 dose 1 doseO 2 doses O
3 to 11 months
2 doses 0 doses 1 dose O
One dose at 12
months of ageO
0 doses 2 doses O 2 doses O No booster dose
1 dose < 12 months 2 doses O 2 doses O No booster dose
1 dose 12 months 1 dose O 1 dose O No booster dose
2 doses < 12 mos. 1 doseO 2 doses O No booster dose
12 to 23 months
1 dose < 12 mos. &
1 dose O 1 doses O No booster dose
1 dose 12 mos
0 doses 1 dose 1 dose No booster dose
Any age- appropriate
series incomplete by 24
months
1 dose O 1 dose O No booster dose
24 to 59 months
Complete PCV7 or PCV
10 series O
0 doses 1 dose O No booster dose
O When an infant has received one or two doses of vaccine, and is subsequently diagnosed with
a high risk medical condition, use the table to complete the immunizations as high risk. When
a high risk condition is diagnosed after an infant has completed the 3 dose schedule for
healthy children, further immunization will be determined on a case-by-case basis.
O High risk children should receive one dose of pneumococcal polysaccharide vaccine at 2 years
of age, and at least 8 weeks after their final pneumococcal conjugate vaccine dose.
O When there is a delay in initiating or completing the vaccine series, use the minimum interval
of 4 weeks between vaccine doses given in infancy. See Section IIA Immunization Schedules,
3.0 Minimum Intervals Between Vaccine Doses.
O At least 8 weeks after the previous dose. O 8 weeks between doses.
O A complete series is:
two (PVC7) or three (PVC7 [high risk] or PCV10) primary doses given at appropriate
intervals and a 3rd or 4
th
dose given on or after 12 months of age and at least 8 weeks after
previous dose, or
a delayed or interrupted schedule that has been completed at a later age according to the
information in this table.
Communicable Disease Control
Immunization Program
Section VII Biological Products
December 2010
Page 46


Recommendations for Pneumococcal Immunization With 13-Valent Pneumococcal
Conjugate Vaccine (PCV 13) and 23-Valent Pneumococcal Polysaccharide Vaccine (PPV
23) for Children at High Risk of Pneumococcal Disease
Age:









Previous doses
PCV 13
Recommendations: OO
None PCV 13 as per primary series schedule O 23 months
None 1 dose of PCV 13, followed by one dose of PPV 23, 8
weeks after the dose of PCV 13.
Once-only revaccination with PPV 23, 3 years after the
first dose of PPV 23 O
24 to 59 months
2 doses PCV13 1dose of PCV 13, followed by one dose of PPV 23, 8
weeks after the dose of PCV 13. before 24 months
Once-only revaccination with PPV 23, 3 years after the
first dose of PPV 23 O
PCV 13 series
completed
One dose of PPV 23 at 24 months of age, O
Once-only revaccination with PPV 23, 3 years after the
first dose of PPV 23 O
One dose of 1 dose of PCV 13, 8 weeks apart, and 8 weeks after
the administration of PPV 23. PPV 23
Once-only revaccination with PPV 23, 3 years after the
first dose of PPV 23 O
O For list of children at high-risk for pneumococcal disease, see Pneumococcal
Conjugate Vaccine (Prevnar

13)
O PPV 23 is provided free
O Children who have completed a PCV13 vaccine series before they are 2 years of
age, and who are among the high risk groups for pneumococcal disease, should
receive one dose of pneumococcal polysaccharide vaccine at 2 years of age, no
sooner than 8 weeks after the last dose of PCV 13.
O If high risk children 2 years of age received pneumococcal polysaccharide vaccine
first, offer pneumococcal conjugate vaccine at least 8 weeks after the polysaccharide
vaccine.
O For list of high-risk conditions for which revaccination with PPV23 is recommended,
see Pneumococcal Polysaccharide Vaccine (Pneumo 23).
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 47


Pneumococcal Polysaccharide Vaccine (Pneumo 23)
Supplier: sanofi pasteur
INDICATIONS Recommended and provided free to:
All persons 65 years of age.

All residents of Extended or Intermediate Care Facilities.

All persons 2 years of age with:
Anatomic or functional asplenia O
Sickle cell disease
Immunosuppression related to disease [e.g., malignant neoplasm
(including leukemia and lymphoma); HIV; multiple myeloma] or
therapy O (e.g., high dose, systemic steroids or severe rheumatoid
arthritis requiring immunosuppressive therapy)
Congenital immunodeficiency states (e.g., complement, properdin
or factor D deficiency)
Chronic heart or lung disease O
Chronic kidney disease
Chronic liver disease including cirrhosis, chronic Hepatitis B,
Hepatitis C
Receipt of hematopoietic stem cell transplant (HSCT)
Solid organ or islet cell transplant (candidate or recipient)
Diabetes
Alcoholism
Cystic fibrosis
Chronic CSF leak
Cochlear implant (candidate or recipient)
HomelessnessO and/or illicit drug use O
INITIAL SERIES Adults and children 2 years of age:
1 dose: 0.5 ml SC or IM OO
HSCT Recipients 2 years of age:
2 doses: 0.5 ml SC or IM 7 months apart (See Section III Immunization
of Special Populations)
Revaccination is not routinely recommended. REINFORCEMENTS

A once-only revaccination should be offered to those who have:
Anatomic or functional asplenia
Sickle cell disease
Immunosuppression related to disease (e.g., HIV, lymphoma,
Hodgkins, multiple myeloma), or therapy (e.g., high dose,
systemic steroids)
Congenital immunodeficiency states (as above)
Chronic kidney disease
Chronic liver disease including cirrhosis, chronic hepatitis B, and
chronic hepatitis C

For individuals >10 years old at time of initial vaccination:
1 dose of 0.5 ml SC or IM 5 years after the initial immunization.

For children 10 years old at time of initial vaccination:
1 dose of 0.5 ml SC or IM 3 years after the initial immunization.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 48







Pneumococcal Polysaccharide Vaccine (Pneumo 23)
Supplier: sanofi pasteur
CONTRAINDICATIONS
History of an anaphylactic reaction to a previous dose of a
pneumococcal vaccine or to any component of Pneumo 23
vaccine
Phenol, monosodium and disodium phosphate VACCINE
COMPONENTS
PRECAUTIONS Adverse reaction may intensify if revaccination occurs within 2
years
Do not administer Pneumo23 and ZOSTAVAX at the same
time due to the possibility of an inferior immune response to
ZOSTAVAX. Separate these vaccines by 4 weeks.

Hodgkins disease:
Do not administer to clients with Hodgkins disease less
than 10 days prior to or during immunosuppressive therapy.
Following intense chemotherapy with or without radiation,
the immune response may be depressed for 2 years. During
the 2 years following completion of treatment, the antibody
response may improve as the interval between treatment
and pneumococcal vaccination increases.
ADVERSE EVENTS Local: Soreness and erythema; rarely severe arthus reaction
Systemic: Occasionally low grade fever
O Give vaccine at least 14 days before elective splenectomy, or, if not possible 14 days
post-splenectomy. If there is concern that the patient may not present later for
immunization, give at hospital discharge.
O Give vaccine before initiation of immunosuppression therapy, and early in the course of
HIV infection.
O Except asthma, unless management involves ongoing high dose oral corticosteroid
therapy.
O Homelessness to be defined by local jurisdiction.
O Crack cocaine smokers have been shown to be at increased risk of invasive
pneumococcal disease.
O Pneumococcal polysaccharide vaccine can be given simultaneously with influenza, Hib,
and meningococcal vaccines, using separate syringes/needles at separate sites.
O Children who are among the high risk groups for pneumococcal disease and who have
completed the PCV 7 vaccine series before they are 2 years of age, should receive one
dose of pneumococcal polysaccharide vaccine at 2 years of age, no sooner than 8 weeks
after the last dose of PCV 7. If high risk children 2 years of age received pneumococcal
polysaccharide vaccine first, offer pneumococcal conjugate vaccine at least 8 weeks after
the polysaccharide vaccine.

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 49


Pneumococcal Polysaccharide Vaccine (Pneumovax 23)
Supplier: Merck Frosst
Recommended and provided free to: INDICATIONS
All persons 65 years of age and all residents of Extended or
Intermediate Care Facilities.
All persons 2 years of age with:
Anatomic or functional asplenia O
Sickle cell disease
Immunosuppression related to disease (e.g., malignant neoplasm
(including leukemia and lymphoma); HIV; multiple myeloma) or
therapy O (e.g., high dose, systemic steroids or severe rheumatoid
arthritis requiring immunosuppressive therapy)
Congenital immunodeficiency states (e.g., complement, properdin
or factor D deficiency)
Chronic heart or lung diseaseO
Chronic kidney disease
Chronic liver disease including cirrhosis, chronic Hepatitis B,
Hepatitis C
Receipt of hematopoietic stem cell transplant (HSCT)
Solid organ or islet cell transplant (candidate or recipient)
Diabetes
Alcoholism
Cystic fibrosis
Chronic CSF leak
Cochlear implant (candidate or recipient)
HomelessnessO and/or illicit drug useO
INITIAL SERIES Adults and children 2 years of age:
1 dose: 0.5 ml SC or IM OO
HSCT Recipients 2 years of age:
2 doses: 0.5 ml SC or IM 7 months apart (See Section III Immunization
of Special Populations)
Revaccination is not routinely recommended. REINFORCEMENTS
A once-only revaccination should be offered to those who have:
Anatomic or functional asplenia
Sickle cell disease
Immunosuppression related to disease (e.g., HIV, lymphoma,
Hodgkins, multiple myeloma), or therapy (e.g., high dose, systemic
steroids)
Congenital immunodeficiency states (as above)
Chronic kidney disease
Chronic liver disease including cirrhosis, chronic hepatitis B, and
chronic hepatitis C

For individuals >10 years old at time of initial vaccination:
1 dose of 0.5 ml SC or IM 5 years after the initial immunization.

For children 10 years old at time of initial vaccination:
1 dose of 0.5 ml SC or IM 3 years after the initial immunization.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 50



Pneumococcal Polysaccharide Vaccine (Pneumovax 23)
Supplier: Merck Frosst
History of an anaphylactic reaction to a previous dose of a
pneumococcal vaccine or to any component of Pneumovax 23
vaccine
CONTRAINDICATIONS
VACCINE
COMPONENTS
Phenol, monosodium and disodium phosphate
PRECAUTIONS Adverse reaction may intensify if revaccination occurs within 2 years
Do not administer Pneumovax23 and ZOSTAVAX at the same
time due to the possibility of an inferior immune response to
ZOSTAVAX. Separate these vaccines by 4 weeks.
Hodgkins Disease:
Do not administer to clients with Hodgkins disease less than 10
days prior to or during immunosuppressive therapy.
Following intense chemotherapy with or without radiation, the
immune response may be depressed for 2 years. During the 2
years following completion of treatment, the antibody response
may improve as the interval between treatment and
pneumococcal vaccination increases.
Local: Soreness and erythema; rarely severe arthus reaction ADVERSE EVENTS
Systemic: Occasionally low grade fever
O Give vaccine at least 14 days before splenectomy, or, if not possible 14 days post-splenectomy.
If there is concern that the patient may not present later for immunization, give at hospital
discharge.
O Give vaccine before initiation of immunosuppression therapy, and early in the course of HIV
infection.
O Except asthma, unless management involves ongoing high dose oral corticosteroids
O Homelessness to be defined by local jurisdiction.
O Crack cocaine smokers have been shown to be at increased risk of invasive pneumococcal
disease.
O Pneumococcal polysaccharide vaccine can be given simultaneously with influenza, Hib, and
meningococcal vaccines, using separate syringes/needles at separate sites.

O Children who are among the high risk groups for pneumococcal disease and who have
completed the PCV 7 vaccine series before they are 2 years of age, should receive one dose of
pneumococcal polysaccharide vaccine at 2 years of age, no sooner than 8 weeks after the last
dose of PCV 7. If high risk children 2 years of age received pneumococcal polysaccharide
vaccine first, offer pneumococcal conjugate vaccine at least 8 weeks after the polysaccharide
vaccine.








Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 51



INDICATIONS INITIAL SERIES
1) Infants and children < 4 years of
age who do not require diphtheria,
pertussis, tetanus, or Hib.






(2) Children 4 years to 17 years of
age who do not require diphtheria or
tetanus vaccine. O

(3) Children and adults who are at
higher risk of exposure to wild
polioviruses: O
health care workers
travellers to areas of countries
where wild polioviruses are circulating
O
workers in refugee camps in
endemic areas
residents of communities in which
a visitor or new refugee/immigrant
may be excreting polioviruses
laboratory workers handling
specimens that may contain
polioviruses
military personnel


(4) Previously unimmunized
children and adult solid organ
transplant (SOT) candidates and
recipients

(5) HSCT recipients: Individuals 7
years of age who are receiving Tdap
concurrently.
(1) Infants and children < 4 years of age:
Dose 1: 0.5 ml SC
Dose 2: 0.5 ml SC give 4 to 8 weeks after dose 1
Dose 3: 0.5 ml SC give 6-12 months after dose 2

Dose 4: 0.5 ml SC at school entry (this dose not
necessary if dose 3 was given on or after the 4
th
birthday)


(2) & (3) Individuals 4 years of age:
Dose 1: 0.5 ml SC
Dose 2: 0.5 ml SC give 4 to 8 weeks after dose 1
Dose 3: 0.5 ml SC give 6-12 months after dose 2

Note: Give 1 dose 0.5 ml SC to children 7 years of age
who have not received a polio booster on or after their 4
th

birthday














(4) Use schedule (1) or (2) above as appropriate for age




(5) Dose 1: 0.5ml SC (12 months after HSCT)
Dose 2: 0.5ml SC (2 months after dose 1)
Dose 3: 0.5ml SC (12 months after dose 1)

Polio Vaccine (Inactivated) (Imovax Polio) (vero cell origin)
Supplier: sanofi pasteur
Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 52


Polio Vaccine (Inactivated) (ImovaxPolio) (vero cell origin)
Supplier: sanofi pasteur
REINFORCEMENTS No additional doses of IPV are recommended for
travellers < 18 years of age who have completed an IPV
or OPV vaccine series.
A single booster dose (10 years after the primary series) is
recommended for individuals 18 years of age who are at
increased risk of exposure to wild polioviruses and who
completed an IPV or OPV series in childhood: health care
workers, travelers to areas of countries where wild
polioviruses are circulating, workers in refugee camps in
polio endemic areas, laboratory workers handling
specimens that may contain polio viruses, and military
personnel.
CONTRAINDICATIONS History of anaphylactic reaction to any polio-containing
vaccine, or to any IPV vaccine component.
VACCINE COMPONENTS 2-phenoxyethanol, formaldehyde, residual calf serum protein,
neomycin, streptomycin, polymyxin B, Medium199 Hanks
ADVERSE EVENTS Minor local reactions, fever.

O Routine polio immunization is not considered necessary for previously unimmunized adults
in Canada who do not intend to travel to areas in which polio outbreaks occur except for
those in Indication (3) above.
O Previously unimmunized travelers who will depart in less than 4 weeks should receive a
single dose of IPV. The remaining doses of vaccine should be given later at the
recommended intervals.

















Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 53


Human Rabies Immune Globulin (RabIg) (HYPERRAB S/D)
Supplier: Talecris Biotherapeutics, Inc.
INDICATIONSOO RABIES POST-EXPOSURE PROPHYLAXIS (RPEP):
As determined by Regional Medical Health Officers.
Consultation is available with Epidemiology Services, BCCDC.
Rabies Vaccine is given in conjunction with Rablg. Rabies
vaccine and Rablg must be administered with separate needles
and syringes at separate anatomical sites
If a rabies vaccine series has been started or completed
elsewhere and it was not given in accordance with the current
WHO standards, or if the vaccine was a nerve tissue vaccine
(Semple vaccine), administer Rablg (on day 0) in conjunction
with another full course of rabies vaccine.
Note: Do not give Rablg if clients were previously immunized in
accordance with the WHO standards or have documented
seroconversion (i.e. level 0.5 IU/ml) within the past 2 years

INITIAL SERIESOO RABIES POST-EXPOSURE PROPHYLAXIS:
The recommended dosage for children and adults is the same:
20 IU/kg of body weight. Because of interference with active
antibody production, do not exceed recommended dose.
The does of Rablg is calculated as:
[20 IU/kg x weight in kg] = ml
150 IU/ml
Rablg is supplied in 2 ml vials, each 1.0 ml = 150 IU
Infiltrate as much Rablg as possible deep into and around the
wound(s) in order to neutralize the virus. When more than one
wound site exists, each site should be infiltrated with a portion of
the Rablg, using a separate syringe and needle for each
infiltration. If there are extensive wounds, where the calculated
dose of Rablg (by weight) is not adequate in volume to infiltrate
all wounds, dilute the Rablg 2-3 fold in normal saline to create an
adequate volume to infiltrate all wounds.
When there is no wound site, the preferred site for the
administration of Rablg is the ventrogluteal area, which may be
used in those > 7 months of age. However, the vastus lateralis is
most often used in infants and children up to 5 years of age.O

None REINFORCEMENTS






Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 54


Human Rabies Immune Globulin (RabIg) (HYPERRAB S/D)
Supplier: Talecris Biotherapeutics, Inc.
CONTRAINDICATIONS 1. There are no contraindications to Rablg given for post-exposure
purposes.
PRECAUTIONS If client has a history of anaphylactic reaction following receipt of
any human Ig product, to any of the components of RabIg
(glycine) or to latex, administer RabIg in an emergency room
setting.
Human Ig products are among the safest blood-derived products
available. The method of preparation includes one or more steps
that exclude or inactivate hepatitis B, C and HIV; therefore the
risk of transmission is extremely low. However, it is possible,
that unknown infectious agents may be present in such products.
Regarding RabIg and the administration of live vaccines (MMR &
Varicella) see Immune Globulin Preparations or Blood: Timing
Intervals For Vaccines Containing Live Measles, Mumps,
Rubella, or Varicella Virus.
Persons with IgA deficiency have the potential for developing
antibodies to IgA and could have an anaphylactic reaction to
subsequent blood products that contain IgA. Administer RabIg in
an emergency room setting.

Fever, headache, malaise, rash, chills. Local tenderness, soreness or
stiffness at the injection site
ADVERSE EVENTS
RabIg contains no preservatives. SPECIAL
CONSIDERATIONS Vials are single dose use: discard unused contents
O Since vaccine induced antibodies begin to appear within one week, there is no value in
administering Rablg more than 8 days after initiation of vaccine.
O Provide a written record to a client who receives any immune globulin product.
O When notification of an exposure is delayed, RPEP may be started as late as 6 or more
months after an exposure.
O The deltoid should not be used for Rablg administration. Both deltoid sites should be
reserved for administration of rabies vaccine.

O See Immune Globulin Preparations (HBlg, Ig, Varlg, Rablg) for maxiumum volume to be
administered per site according to age.









Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 55



Rabies Vaccine Pre-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated)
Imovax Rabies O
Supplier: sanofi Pasteur
INDICATIONS PRE-EXPOSURE PROPHYLAXIS:
Provided free to:
BC students attending a Canadian Veterinary College or Animal
Health Tech Training Centre.

Recommended but not provided free to the following persons at
risk of contact with the rabies virus:
High Risk:
Rabies research lab workers
Rabies biologicals production workers
Moderate Risk:
Rabies diagnostic lab workers
Spelunkers
Veterinarians and staff, and animal control workers in rabies
epizootic areas
Hunters and trappers in high risk areas such as the far north
Low Risk:
Vets and staff, and animal control and wildlife workers in areas of
low rabies disease (enzootic)
Vet students and animal health tech students (however, vaccine is
provided free to this group)
Children and travelers visiting foreign epizootic areas for 1 month
or more
PRE-EXPOSURE PROPHYLAXIS: INITIAL SERIES

1.0ml IM (2.5 IU) at dosage intervals of 0 - 7 - 21 days
For infants and children < 12 months of age, the site for
immunization is the anterolateral thigh.
For infants 12 months of age and adults, the preferred site is the
deltoid muscle.

DO NOT GIVE RABIES VACCINE IN THE GLUTEAL REGION.


ROUTE While NACI considers the IM route of administration as the gold
standard, consideration may be given to using the ID route of
administration for pre-exposure immunization provided there is an
opportunity to assess the neutralizing antibody level at least 1 month
after administration, so that adequate protection can be ensured.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 56



Rabies Vaccine Pre-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated) Imovax
Rabies
Supplier: sanofi Pasteur
REINFORCEMENTS As required 1.0 ml IM. An acceptable antibody level is 0.5 IU/ml.
High risk: test clients every 6 mos. and boost when level falls below
0.5 IU/ml.
Moderate risk: test clients every 2 years and boost when level falls
below 0.5 IU/ml.
Low risk: testing not required and no routine booster for clients.
1. Persons with an anaphylactic reaction to a previous dose of rabies
vaccine, Imovax Rabies, any component of Imovax Rabies, or
to latex.
CONTRAINDICATIONS
2. Severe allergic or neuroparalytic reactions during the course of a
rabies vaccine series pose a serious dilemma. The risk of
exposure to rabies must be carefully considered before a decision
is made to discontinue rabies vaccine.
Human albumin, neomycin sulfate, phenol red, and beta
propiolactone.
VACCINE
COMPONENTS
PRECAUTIONS Persons receiving high doses of steroids or immunosuppressive
therapy should receive vaccine by the IM route and have a rabies
antibody titre upon completion to ensure an adequate response
has developed. If titre is inadequate, give one booster dose and
retest.
Persons taking chloroquine should receive vaccine by the IM route
or be vaccinated by the ID route at least 1 month prior to their
taking chloroquine.
There are insufficient data regarding concurrent use of mefloquine
with rabies immunization.
ADVERSE EVENTS Fever, nausea, headache, muscle aches, abdominal pain, fatigue, and
dizziness. Pain, redness, swelling and itching at injection site. Three
cases of neurologic illness resembling Guillain-Barr syndrome (GBS)
were reported in the early 1980s; all cases resolved without sequelae
within 12 weeks.
SPECIAL
CONSIDERATIONS
Imovax Rabies is pink to red in color following reconstitution. Also, it
does not contain any preservative and should be used immediately
after reconstitution or discarded.
O Whenever possible the immunization series should be completed with the same product.
However, if this is not feasible, Imovax and RabAvert are interchangeable in terms of
indications for use, immunogenicity, efficacy, and safety.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 57


Rabies Vaccine Post-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated)
ovaxRabies
Supplier: sanofi pasteur
INDICATIONS Post-Exposure Prophylaxis:
As determined by Regional Medical Health Officers.
Consultation is available with Epidemiology Services, BCCDC.
If a rabies vaccine series has been started or completed
elsewhere and it was not given in accordance with current WHO
standards, or if the vaccine was a nerve tissue vaccine (Semple
vaccine), administer another full course of rabies vaccine.
Administer RabIg on day 0 of vaccine series.
SERIES

Unimmunized: OO
(1) 1.0 ml IM on days 0 3 7 14 - 28

Day 0: 1.0 ml IM as soon as possible after exposure PLUS
RabIg
Days 3, 7, 14 and 28: 1.0 ml IM

Previously immunized:OOO
(1) Completion of a course of pre/post-exposure prophylaxis with
rabies vaccine 2 years previously that used a WHO approved
rabies vaccine and schedule
OR
(2) Completion of a course of rabies pre/post exposure prophylaxis
that used a non-WHO approved vaccine or schedule OR
completion of a course of rabies pre/post exposure prophylaxis
> 2 years previously that used a WHO approved vaccine and
schedule AND expedited rabies antibody titre result
0.5 IU/mlO
Give rabies vaccine on day 0 (as soon as possible after
exposure) & on day 3: 1.0 ml IM
(DO NOT GIVE RabIg)

(3) Completion of a course of rabies pre/post exposure prophylaxis
that used a non-WHO approved vaccine or schedule OR
completion of a course of rabies pre/post exposure prophylaxis
> 2 years previously that used a WHO approved vaccine and
schedule AND expedited rabies antibody titre result < 0.5IU/mlO
Give rabies vaccine on day 0 (as soon as possible after
exposure) & on days 3, 7, 14, 28: 1.0 ml IM
(DO NOT GIVE RabIg)
1. There are NO contraindications to rabies vaccine given for post-
exposure purposes.
2. DO NOT GIVE RABIES VACCINE IN THE GLUTEAL REGION.
CONTRAINDICATIONS
3. Rabies vaccine and RabIg must NOT be administered in the
same anatomical site. Use separate needles and syringes for
each product.
Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 58



Rabies Vaccine Post-exposure [Human Diploid Cell Vaccine (HDCV)] (Inactivated) Imovax
Rabies
Supplier: sanofi pasteur
VACCINE
COMPONENTS
Human albumin, neomycin sulfate, phenol red and beta propiolactone.
PRECAUTIONS Administer vaccine in an emergency room setting if history of an
anaphylactic reaction to a previous dose of rabies vaccine,
Imovax Rabies, to any of the components of ImovaxRabies or
to latex.

Persons receiving high doses of steroids or immunosuppressive
therapy should receive vaccine by the IM route and have a rabies
antibody titre upon completion to ensure an adequate response
has developed. If titre is inadequate, give one booster dose and
retest.

There are insufficient data regarding concurrent use of
mefloquine with rabies immunization.
Fever, nausea, headache, muscle aches, abdominal pain, fatigue,
and dizziness. Pain, redness, swelling and itching at injection site.
Three cases of neurologic illness resembling Guillain-Barr syndrome
(GBS) were reported in the early 1980s; all cases resolved without
sequelae within 12 weeks.
ADVERSE EVENTS
SPECIAL
CONSIDERATIONS
Imovax Rabies is pink to red in color following reconstitution. Also, it
does not contain any preservative and should be used immediately
after reconstitution or discarded.
O Whenever possible the immunization series should be completed with the same product.
However, if this is not feasible, ImovaxRabies and RabAvert are interchangeable in terms of
indications for use, immunogenicity, efficacy, and safety.
O In infants and children <12months of age, the site for immunization is the anterolateral thigh. For
children 12 months of age and adults, the preferred site is the deltoid.




O Have serum sample taken and administer first dose of rabies vaccine while awaiting results.
Phone BCCDC Laboratory Services with clients demographics: 1-877-747-2522. It is very likely
the rabies antibody titre result will not be available by day 7: administer 3
rd
dose of rabies
vaccine on day 7.






Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 59



Rabies Vaccine Pre-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine]
(PCECV)
Supplier: Novartis
INDICATIONS PRE-EXPOSURE PROPHYLAXIS: Provided free to:
BC students attending a Canadian Veterinary College or Animal
Health Tech Training Centre.

Recommended but not provided free to the following persons at
risk of contact with the rabies virus:
High Risk:
Rabies research lab workers
Rabies biologicals production workers
Medium Risk:
Rabies diagnostic lab workers
Spelunkers
Veterinarians and staff, and animal control workers in rabies
epizootic areas
Hunters and trappers in high risk areas such as the far north
Low Risk:
Vets and staff, and animal control and wildlife workers in areas of
low rabies disease (enzootic)
Vet students and animal health tech students (however, vaccine
is provided free to this group)
Children and travelers visiting foreign epizootic areas for 1 month
or more
PRE-EXPOSURE PROPHYLAXIS: INITIAL SERIESO
1.0 ml IM (2.5 IU) at dosage intervals of 0 - 7 - 21 days
In infants and children < 12 months of age, the site for
immunization is the anterolateral thigh.
For children 12 months of age and adults, the preferred site is
the deltoid muscle.
NACI considers the IM route of administration as the gold standard,
consideration may be given to using the ID route of administration for
pre-exposure immunization provided there is an opportunity to
assess the neutralizing antibody level at least 1 month after
administration, so that adequate protection can be ensured.
ROUTE
REINFORCEMENTS As required 1.0 ml IM. An acceptable antibody level is 0.5 IU/ml.
High risk: test clients every 6 mos. and boost when level falls
below 0.5 IU/ml.
Moderate risk: test clients every 2 years and boost when level
falls below 0.5 IU/ml.
Low risk: testing not required and no routine booster for clients.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 60



Rabies Vaccine Pre-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine] (PCECV)
Supplier: Novartis
RECONSTITUTION
Use the longer of the 2 needles supplied (21g x 1.5) to
withdraw the entire contents of the sterile diluent into the
syringe. Insert the needle at a 45 angle and slowly inject the
entire contents of the diluent into the vaccine vial. Mix gently to
avoid foaming. Unscrew the syringe from the needle to
eliminate negative pressure. Reinsert the syringe into the
needle. Withdraw the total amount of reconstituted vaccine into
the syringe. Replace the long needle with the smaller needle
(25g x 1) for IM injection.
CONTRAINDICATIONS
1. Persons with a history of anaphylaxis to a previous dose of
rabies vaccine, RabAvert, eggs or egg products, or to any
component of RabAvert.
2. Severe allergic or neuroparalytic reactions during the course of
a rabies vaccine series pose a serious dilemma. The risk of
exposure to rabies must be carefully considered before a
decision is made to discontinue rabies vaccine.
VACCINE
COMPONENTS
Polygeline (processed bovine gelatin stabilizer), human serum
albumin, ovalbumin (egg white albumin), neomycin, chlortetracycline,
amphotericin B, potassium glutamate, sodium EDTA.
PRECAUTIONS Persons receiving high doses of steroids or
immunosuppressive therapy should receive vaccine by the IM
route and have a rabies antibody titre upon completion to
ensure an adequate response has developed. If titre is
inadequate, give one booster dose and retest.
Persons taking chloroquine should receive vaccine by the IM
route or be vaccinated by the ID route at least 1 month prior to
their taking chloroquine.
There are insufficient data regarding concurrent use of
mefloquine with rabies immunization.
ADVERSE EVENTS Fever, nausea, headache, muscle aches, abdominal pain, fatigue,
and dizziness. Pain, redness, swelling and itching at injection site.
Three cases of neurologic illness resembling Guillain-Barr
syndrome (GBS) were reported in the early 1980s; all cases
resolved without sequelae within 12 weeks.

SPECIAL
CONSIDERATIONS
RabAvert does not contain a preservative and should be used
immediately after reconstitution or discarded.
O Whenever possible the immunization series should be completed with the same product.
However, if this is not feasible, RabAvert and Imovax are interchangeable in terms of
indications for use, immunogenicity, efficacy, and safety.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 61


Rabies Vaccine Post-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine (PCECV)]
Supplier: Novartis
INDICATIONS Post-exposure prophylaxis:
As determined by Regional Medical Health Officers. Consultation
is available with Epidemiology Services.
If a rabies vaccine series has been started or completed
elsewhere and it was not given in accordance with current WHO
standards, or if the vaccine was a nerve tissue vaccine (Semple
vaccine), administer another full course of rabies vaccine.
Administer RabIg on day 0 of vaccine series.
SERIES Unimmunized:OO

(1) 1.0 ml IM given on days 0 3 7 14 - 28

Day 0: 1.0 ml IM as soon as possible after exposure PLUS RabIg
Days 3, 7, 14 and 28: 1.0 ml IM

Previously immunized:OO

(1) Completion of a course of pre/post-exposure prophylaxis with
rabies vaccine 2 years previously that used a WHO approved
rabies vaccine and schedule
OR
(2) Completion of a course of rabies pre/post exposure prophylaxis
that used a non-WHO approved vaccine or schedule OR
completion of a course of rabies pre/post exposure prophylaxis
> 2 years previously that used a WHO approved vaccine and
schedule AND expedited rabies antibody titre result 0.5 IU/ml O
Give rabies vaccine on day 0 (as soon as possible after
exposure) & on day 3: 1.0 ml IM
(DO NOT GIVE RabIg)

(3) Completion of a course of rabies pre/post exposure prophylaxis
that used a non-WHO approved vaccine or schedule OR
completion of a course of rabies pre/post exposure prophylaxis >
2 years previously that used a WHO approved vaccine and
schedule AND expedited rabies antibody titre result < 0.5 IU/ml O
Give rabies vaccine on day 0 (asap after exposure) & on days
3, 7, 14, 28: 1.0 ml IM
(DO NOT GIVE RabIg)


Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 62


Rabies Vaccine Post-exposure (RabAvert) [Purified Chick Embryo Cell Vaccine
(PCECV)]
Supplier: Novartis
Use the longer of the 2 needles supplied (21g x 1.5) to withdraw
the entire contents of the sterile diluent into the syringe. Insert the
needle at a 45 angle and slowly inject the entire contents of the
diluent into the vaccine vial. Mix gently to avoid foaming. Unscrew
the syringe from the needle to eliminate negative pressure.
Reinsert the syringe into the needle. Withdraw the total amount of
reconstituted vaccine into the syringe. Replace the long needle
with the smaller needle (25g x 1) for IM injection.
RECONSTITUTION
CONTRAINDICATIONS
1. There are NO contraindications to rabies vaccine given for
post-exposure purposes.
2. DO NOT GIVE RABIES VACCINE IN THE GLUTEAL
REGION.
3. Rabies vaccine and HRIG must NOT be administered in the
same anatomical site. Use separate needles and syringes for
each product.
Polygeline (processed bovine gelatin stabilizer), human serum
albumin, ovalbumin (egg white albumin), neomycin,
chlortetracycline, amphotericin B, potassium glutamate and
sodium EDTA.
VACCINE
COMPONENTS
PRECAUTIONS Administer vaccine in an emergency room setting if history of
anaphylactic reaction to a previous dose of rabies vaccine,
RabAvert, eggs or egg products, or to any of the
components of RabAvert.
Persons receiving high doses of steroids or
immunosuppressive therapy should receive vaccine by the
IM route and have a rabies antibody titre upon completion to
ensure an adequate response has developed.
There are insufficient data regarding concurrent use of
mefloquine with rabies immunization.
Fever, nausea, headache, muscle aches, fatigue, abdominal pain
and dizziness. Pain redness, swelling and itching at injection site.
Three cases of neurologic illness resembling Guillain-Barr
syndrome (GBS) were reported in the early 1980s; all cases
resolved without sequelae within 12 weeks.
ADVERSE EVENTS
SPECIAL
CONSIDERATIONS
RabAvert does not contain a preservative and should be used
immediately after reconstitution or discarded.
O Whenever possible the immunization series should be completed with the same product. However, if this is not
feasible, ImovaxRabies and RabAvert are interchangeable in terms of indications for use, immunogenicity,
efficacy, and safety.
O In infants and children <12months of age, the site for immunization is the anterolateral thigh. For children 12
months of age and adults, the preferred site is the deltoid.
O Have serum sample taken and administer first dose of rabies vaccine while awaiting results. Phone BCCDC
Laboratory Services with clients demographics: 1-877-747-2522. It is very likely the rabies antibody titre result
will not be available by day 7: administer 3
rd
dose of rabies vaccine on day 7.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 62a


Rotavirus Vaccine (Pentavalent Human-bovine reassortant) (Oral live attenuated viral)
(RotaTeq)
Supplier: Merck Frosst Canada, Inc.
INDICATIONS Recommended but not currently provided free to:
Infants who can commence immunization at > 6 weeks of
age and up to 15 weeks (14 weeks plus 6 days) of ageO O
INITIAL SERIES 3 doses: Entire contents of tube (2 ml) by mouth, each dose
at least 4 weeks apart O O O O O O OG
The maximum age for the first dose is 14 weeks plus 6 days
of age.
Administer last dose by 32 weeks of age.
Not indicated at this time. REINFORCEMENTS
CONTRAINDICATIONS
2. History of anaphylactic reaction to a previous dose of
rotavirus vaccine, or to any component of RotaTeq.
3. Infants with a history of intussusception.
4. Infants with a suspected or known immunocompromising
condition should not receive RotaTeq without consultation
with a physician specialist or expert in the condition.
PRECAUTIONS
1. Acute gastroenteritis: in infants with moderate to severe
gastroenteritis, rotavirus vaccine should be deferred until the
condition improves unless deferral will result in scheduling of
the first dose at > 14 weeks plus 6 days of age. Infants with mild
gastroenteritis can be vaccinated.

2. Pre-existing chronic gastrointestinal conditions: the safety
and efficacy of RotaTeq has not been established in children
with pre-existing chronic gastrointestinal conditions. However,
infants with chronic gastrointestinal disease who are not
receiving immunosuppressive therapy are likely to benefit from
rotavirus vaccination and therefore can be vaccinated.
VACCINE
COMPONENTS
Sucrose, sodium citrate dihydrate, sodium phosphate
monobasic monohydrate, sodium hydroxide, polysorbate 80,
trace amounts of fetal bovine serum, porcine circovirus types 1
and 2.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 62b


Rotavirus Vaccine (Pentavalent Human-bovine reassortant) (Oral live attenuated
viral) (RotaTeq)
Supplier: Merck Frosst Canada, Inc.
ADVERSE EVENTS Fever, diarrhea, vomiting, nasopharyngitis, bronchospasm,
irritability.
O Preterm infants who are between 6 weeks (6 weeks and 0 days) and 32 weeks of
chronological age that are healthy and not hospitalized can receive Rotateq vaccine.
O Infants who have had rotavirus gastroenteritis before receiving the full course of
vaccinations should still initiate or complete the RotaTeq schedule because the initial
infection frequently provides only partial immunity.
O The first dose should not be given after 14 weeks plus 6 days of age.
O There should be an interval of at least 4 weeks between doses.
O All doses should be administered by 32 weeks of age.
O For infants in whom the first dose of RotaTeq vaccine is inadvertently administered off
label at age 15 weeks, the rest of the RotaTeq vaccination series should be
completed with a minimum of 4 weeks between doses. All doses should be
administered by 32 weeks of age.
O If an infant spits out or regurgitates any of the vaccine dose, no replacement dose
should be administered.
O There are no restrictions on the infants consumption of food or liquid, including breast
milk, either before or after vaccination.
O Rotateq vaccine may be administered at any time before, concurrently with, or after
administration of any blood product, including antibody-containing products.
G There are no data on the interchangeability of Rotateq and Rotarix vaccines.
Whenever possible, the series should be completed with the same product. However, if
the product used for a previous dose(s) is not known, complete the series with the
available product. If any dose in the series was Rotateq, a total of 3 doses of vaccine
should be administered.
There is no evidence that porcine circovirus types 1 and 2 pose a safety risk in humans
and neither virus causes infection or illness in humans. These viruses are commonly
found in pigs and pork products, but are not pork products.

Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 62c



Rotavirus Vaccine (Human rotavirus, live attenuated, oral vaccine) (Rotarix)
Supplier: GlaxoSmithKline
INDICATIONS Recommended but not currently provided free to:
Infants who can commence immunization at > 6 weeks of
age and up to 15 weeks (14 weeks plus 6 days) of ageO O
INITIAL SERIES

2 doses: 1.5 ml (entire contents of applicator) by mouth at
least 4 weeks apart O O O O O O OGThe maximum age
for the first dose is 14 weeks plus 6 days of age.
Administer second dose before 32 weeks of age.
REINFORCEMENTS Not indicated at this time.
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of
rotavirus vaccine, or to any component of Rotarix.
2. Infants with a history of intussusception.
3. Infants with a suspected or known immunocompromising
condition should not receive Rotarix without consultation
with a physician specialist or expert in the condition.
PRECAUTIONS

1. Acute gastroenteritis: in infants with moderate to severe
gastroenteritis, rotavirus vaccine should be deferred until the
condition improves unless deferral will result in scheduling of
the first dose at > 14 weeks plus 6 days of age. Infants with
mild gastroenteritis can be vaccinated.
2. Pre-existing chronic gastrointestinal conditions: the safety
and efficacy of Rotarix has not been established in children
with pre-existing chronic gastrointestinal conditions. However,
infants with chronic gastrointestinal disease who are not
receiving immunosuppressive therapy are likely to benefit from
rotavirus vaccination and therefore can be vaccinated.

VACCINE
COMPONENTS
Sucrose, Dulbeccos Modified Eagle Medium (DMEM), di-
sodium adipate, sterile water, porcine circovirus types 1 and
2.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 62d


Rotavirus Vaccine (Human rotavirus, live attenuated, oral vaccine) (Rotarix)
Supplier: GlaxoSmithKline
Loss of appetite, irritability, fever, fatigue, diarrhea, vomiting or
regurgitation of food, flatulence and abdominal pain.
ADVERSE EVENTS
O Preterm infants who are between 6 weeks (6 weeks and 0 days) and 32 weeks
chronological age that are healthy and not hospitalized can receive Rotarix vaccine.
O Infants who have had rotavirus gastroenteritis before receiving the full course of
vaccinations should still initiate or complete the Rotarix schedule because the initial
infection frequently provides only partial immunity.
O The first dose should not be given after 14 weeks plus 6 days of age.
O There should be an interval of at least 4 weeks between doses.
O All doses should be administered by 32 weeks of age.
O For infants in whom the first dose of Rotarix vaccine is inadvertently administered off
label at age 15 weeks, the rest of the Rotarix vaccination series should be
completed with a minimum of 4 weeks between each dose. All doses should be
administered by 32 weeks of age.
O If an infant spits out or regurgitates any of the vaccine dose, no replacement dose
should be administered.
O There are no restrictions on the infants consumption of food or liquid, including breast
milk, either before or after vaccination.
O Rotarix vaccine may be administered at any time before, concurrently with, or after
administration of any blood product, including antibody-containing products.
G There are no data on the interchangeability of Rotateq and Rotarix vaccines.
Whenever possible, the series should be completed with the same product. However,
if the product used for a previous dose(s) is not known, complete the series with the
available product. If any dose in the series was Rotateq, a total of 3 doses of
vaccine should be administered.
There is no evidence that porcine circovirus types 1 and 2 pose a safety risk in
humans and neither virus causes infection or illness in humans. These viruses are
commonly found in pigs and pork products, but are not pork products.

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 63


Tetanus-Diphtheria (Td) Adsorbed
Supplier: sanofi pasteur
INDICATIONS (1) Booster dose for persons 7 years of age if both diphtheria
and tetanus are required, but polio is not required. Preferred
product for wound management in this age group.

(2) Adults 18 years of age who have not been immunized,
including immigrants with unknown immunization status

(1) 0.5 ml IM every 10 years O DOSE


(2) Administer one dose of Adacel followed by two doses of
Td:
1
st
Td: 0.5 ml IM 1 month after Adacel
2
nd
Td: 0.5 ml IM 6 12 months after 1
st
Td dose

REINFORCEMENTS
Every 10 yearsO
CONTRAINDICATIONS
1. History of anaphylactic reaction to a previous dose of any
tetanus or diphtheria-containing vaccine, or to any Td vaccine
component.
2. When a contraindication exists to tetanus toxoid and a client
sustains a major or unclean wound TIG should be given (see
Tetanus Immune Globulin (TIg) (HYPERTET S/D).
3. History of Guillain-Barr syndrome (GBS) occurring within 8
weeks of receipt of a tetanus containing vaccine.
VACCINE
COMPONENTS
Aluminum phosphate and formaldehyde.
PRECAUTIONS Persons who experience a major local reaction or high fever
following a dose of Td should not be given another dose for
at least 10 years.
When travel to a developing country is planned >5 years after
the last Td dose, it may be prudent to offer an early booster,
since some developing countries may not be able to
guarantee the safe administration of a booster dose if
required.
Discomfort, pain, swelling, redness at injection site. ADVERSE EVENTS
For wound prophylaxis, Td and Tetanus Immune Globulin should
be administered using separate syringes and different sites.
SPECIAL
CONSIDERATIONS
O Tetanus toxoid should not be given routinely to clients who have received a booster
dose in the previous 5 years.



Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 64


Tetanus-Diphtheria-acellular Pertussis (Tdap) (ADACEL)
Supplier: sanofi pasteur
INDICATIONS O O INITIAL SERIES
(1) Reinforcing dose for all grade 9 students O (1) One dose: 0.5 ml IM

(2) Children and adolescents from 7 years to
17 years of age (inclusive) who have not
received any doses of tetanus or diphtheria


(2) (3) Dose 1: 0.5 ml IM
& (4) Dose 2: 0.5 ml IM 1 month later
(3) Children and adolescents from 7 years to
17 years of age (inclusive) who have not
received any doses of pertussis vaccine
Dose 3: 0.5 ml IM 6 to 12 months
after dose 2
(4) Immigrants from 7 years to 17 years of age
(inclusive) with unknown immunization status
(5) Children and adolescents from 7 years to
17 years of age (inclusive) whose 3 dose
primary series of tetanus or diphtheria or
pertussis vaccine is incomplete
(5) One to two doses of ADACEL (0.5
ml IM) at time of presentation to
complete the primary series of 3
doses, followed by another dose of
0.5 ml IM in grade 9O
(6) One dose of ADACEL (0.5 ml IM)
at time of presentation, followed by
another dose of 0.5 ml IM
in grade 9 O
(6) Children and adolescents from 7 years to
17 years of age (inclusive) who have
received 3 4 doses of
tetanus/diphtheria/pertussis-containing
vaccine at < 7 years of age, but have not
received the school entry booster
(7) One dose of ADACEL (0.5ml IM)
followed by two doses of Td
(7) Adults 18 years of age who have not
been immunized, including immigrants with
unknown immunization status

(8) HSCT recipients 7 to <18 years of age (8) Three doses of ADACEL (0.5ml
IM) at 0, 1, and 12 months.
(9) HSCT recipients 18 years of age

(10) Solid organ transplant candidates or
recipients 7 years of age who have not been
previously immunized.

(9)& (10) One dose of ADACEL (0.5ml
IM) followed by two doses of Td/IPV
REINFORCEMENTS
Not publicly funded for booster immunization
of those 18 years old.
Communicable Disease Control
Immunization Program
Section VII Biological Products
May 2010
Page 65


Tetanus-Diphtheria-acellular Pertussis (Tdap) (ADACEL)
Supplier: sanofi pasteur
1. History of an anaphylactic reaction to a previous dose of any
tetanus, diphtheria, or pertussis-containing vaccine or to any
component of ADACEL vaccine.
CONTRAINDICATIONS
2. History of Guillain-Barr syndrome (GBS) occurring within 8
weeks of receipt of a tetanus containing vaccine.
Aluminum phosphate, 2-phenoxyethanol.
VACCINE
COMPONENTS
Minor local: redness, tenderness, swelling, induration, pain ADVERSE EVENTS
Minor systemic: headache, decreased energy, generalized body-
ache, nausea, diarrhea, fever, sore or swollen joints
O There should be a minimum of 2 years since receipt of a previous booster dose of a
tetanus/diphtheria containing vaccine. The exception to this, for Grade 9 ADACEL
program only, is a minimum interval of 6 months. This recommendation is based on
unpublished data. In studies related to the interval between the grade 9 Tdap booster and
a previous dose of a tetanus-containing vaccine, there were a small number of students
with an interval of ~ 6 months since receipt of a tetanus-containing vaccine. Following
administration of the grade 9 tetanus booster they did not experience any marked local
reactions.
O According to the National Advisory Committee on Immunization (NACI), there is no upper
age limit for the administration of Tdap. This differs from the information in the Tdap
product monograph.
O Give Tdap to high school students who missed their grade 9 booster.





O For example, if the student had received one dose of a tetanus/diphtheria/pertussis
containing vaccine, give two doses of ADACEL, separated by a period of 6 - 12 months.
If the student had received two doses of a tetanus/diphtheria/pertussis containing
vaccine, give one dose of ADACEL

Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 66


Tetanus-Diphtheria-Inactivated Poliomyelitis Adsorbed (Td/IPV)
Supplier: sanofi pasteur
INDICATIONSO (1) Primary immunization of those 7 years of age when polio
vaccine is indicated.

(2) Solid organ transplant candidates or recipients 7 years of
age when polio vaccine is indicated.
(3) HSCT recipients 18 years of age
(1)(2) Dose 1: 0.5 ml IM INITIAL SERIES
Dose 2: 0.5 ml IM 4-8 weeks after 1
st
dose.
Dose 3: 0.5 ml IM 6-12 months after 2
nd
dose
(3) One dose of Tdap followed by 2 doses of Td/IPV.
REINFORCEMENTS Following completion of the primary series, booster doses are Td
vaccine 0.5 ml IM every 10 years (see Tetanus-Diphtheria (Td)
Adsorbed) O
ROUTE IM
1. History of anaphylactic reaction to a previous dose of any tetanus,
diphtheria, or polio-containing vaccine or to any Td/IPV vaccine
component.
CONTRAINDICATIONS
2. When a contraindication exists to tetanus toxoid and a client
sustains a major or unclean wound TIG should be given (Refer to
Tetanus Prophylaxis in Wound Management).
3. History of Guillain-Barr syndrome (GBS) occurring within 8 weeks
of receipt of a tetanus containing vaccine.
VACCINE
COMPONENTS
Aluminum phosphate, formaldehyde, albumin (human), neomycin,
polymyxin B and 2-phenoxyethanol
ADVERSE EVENTS Discomfort, pain, swelling, redness at site.
SPECIAL
CONSIDERATIONS
For wound prophylaxis, Td/IPV and Tetanus Immune Globulin should
be administered using separate syringes and different sites (i.e., when
polio vaccine is also required, otherwise Td is the vaccine of choice
for wound management).
O Routine immunization against polio of adults living in Canada is not considered necessary.
However, primary immunization with polio vaccine is recommended for certain categories of
adults (see IPV monovalent vaccine indication section).
O Booster doses of IPV vaccine are not routinely recommended, but a single dose of IPV (10
years after the primary series) may be considered for those persons at greater risk of
exposure to wild polioviruses (i.e., health care workers, travelers to areas of countries where
wild polioviruses are circulating, workers in refugee camps in polio endemic areas, laboratory
workers handling specimens that may contain polio viruses, and military personnel).


If only polio vaccine is required, give IPV monovalent vaccine; if tetanus and diphtheria are
also required give Td/IPV vaccine.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 67


Tetanus Immune Globulin (TIg) (HYPERTETS/D)
Supplier: Talecris Biotherapeutics, Inc.
INDICATIONSO
1) TIg is indicated for prophylaxis against tetanus following a major
or unclean wound in individuals whose immunization history is
incomplete or uncertain (See Tetanus Prophylaxis in Wound
Management.)

2) TIg is indicated when a contraindication to a tetanus toxoid-
containing vaccine exists and an individual sustains a major or
unclean wound.

3) TIg is indicated in individuals known to have a significant
immune deficiency state (i.e. HIV) regardless of their
immunization history, following any major or unclean wound.
Give 250 units IM (entire syringe) to adults and children who require
TIg. O
DOSE

TIg is supplied in a 250 unit single dose pre-filled disposable syringe.

The syringe fill volume for each lot is adjusted to ensure a potency of
250 IU/syringe. The actual fill volume for HyperTet syringes typically
ranges between 0.75 ml and 1.3 ml. The needle on the pre-filled
syringe is fixed and cannot be changed.
REINFORCEMENTS None if Td vaccine is given concurrently with TIg. OO
CONTRAINDICATIONS
TIg should not be given intravenously.
O Provide a written record to a client who receives any immune globulin product.
O See Immune Globulin Preparations (HBIg, Ig, VarIg, RabIg) for maximum volume to be
administered per site according to age
O If a contraindication to a tetanus toxoid-containing vaccine exists or a client refuses a tetanus
toxoid-containing vaccine, and a client sustains a major or unclean wound, consider offering
a 2
nd
dose of TIg 30 days post the 1
st
dose of TIg.

O Tetanus Immune Globulin does not interfere with the development of active immunity from a
tetanus toxoid-containing vaccine










Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 68


Tetanus Immune Globulin (TIg) (HYPERTETS/D)
Supplier: Talecris Biotherapeutics, Inc.
Human Ig products are among the safest blood-derived
products available. The method of preparation includes one or
more steps that exclude or inactivate hepatitis B, C and HIV;
therefore the risk of transmission is considered to be extremely
low. However, it is possible that unknown infectious agents
may be present in such products.

PRECAUTIONS
Regarding TIg and administration of live vaccines (MMR &
Varicella) see Immune Globulin Preparations or Blood: Timing
Intervals For Vaccines Containing Live Measles, Mumps,
Rubella, or Varicella Virus.

Give TIg with caution (i.e., in a setting capable of managing
anaphylaxis) if the client has a history of anaphylactic reaction
following receipt of any human Ig product, or a history of
anaphylactic reaction to latex (assess risks versus benefits).

Persons with IgA deficiency have the potential for developing
antibodies to IgA and could have an anaphylactic reaction to
subsequent administration of blood products that contain IgA.
Therefore, TIg should only be given to such persons if the
expected benefits outweigh the risks.

In clients who have severe thrombocytopenia or any
coagulation disorder that would contraindicate IM injections, TIg
should be given only if the expected benefits outweigh the risks.

TIg must be given at separate anatomic sites from a
tetanus toxoid-containing vaccine.



The preferred site for the administration of TIg is the
ventrogluteal area, which may be used in those > 7 months of
age. However, the vastus lateralis is most often used in infants
and children up to 5 years of age.

ADVERSE EVENTS Local tenderness, erythema and stiffness of local muscles that may
persist for several hours. Systemic reactions include mild fever or
malaise.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 69


Tetanus Prophylaxis in Wound Management
Clean, minor wounds All other wounds O History of
Tetanus
Immunization
Tetanus Toxoid-
Containing
Vaccine O
Tetanus Toxoid-
Containing
Vaccine O
TIg TIg
Yes No Yes Yes Uncertain or < 3
doses
Primary
immunization
complete OO
Yes O No Yes O No O
O Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva;
puncture wounds; tearing away of body parts or structures; and wounds resulting from
missiles, crushing, burns and frostbite.
O May have been given as Td, Tdap, or Td/IPV. Monovalent tetanus toxoid is not available
in Canada.
O For additional information on the primary immunization schedule, refer to the Td, Tdap, or
Td/IPV vaccine pages.
O Wound management for children < 7 years of age would be based on specific spacing
and doses required as per INFANRIX hexa, PEDIACEL and QUADRACEL vaccine
pages.
O Yes, unless there is documentation of a booster within the last 10 years.
O Yes, unless there is documentation of a booster within the last 5 years.
O No, unless individuals are known to have a significant humoral immune deficiency state
(e.g., HIV, agammaglobulinemia), since immune response to tetanus toxoid may be sub-
optimal.

Note: Tetanus-diphtheria (Td) vaccine and Tetanus Immune Globulin (TIg) should be
administered using separate syringes and different sites. If a contraindication exists for a
tetanus toxoid-containing vaccine, TIg would be given where tetanus immunization is
required.
Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 70


Tuberculin Skin Test (Mantoux) Tubersol
Supplier: sanofi pasteur
Recommended and provided free for: INDICATIONS
Suspected cases of TB
Individuals referred for medical diagnostic reason
Contacts of a known case of TB
Screening programs for select groups of persons judged to be at
high risk
HIV positive individuals and persons at significant risk for HIV
infection
Fee for testing is applicable for:
International travelers who will be residing in countries where TB
is endemic and travelers returning from prolonged visits to
endemic areas.
Establishment of a baseline prior to possible exposure to TB (as a
requirement for an educational program, volunteer position or
employment)
Self-referral
Pre-landing immigration testing
PPD 5 TU 0.1 ml ID in anterior forearm (flexor or dorsal surface)
between the wrist and the elbow
INITIAL SERIES
For contact tracing, if the initial skin test is negative, a second test
should be given 8 12 weeks after the last date of contact
REINFORCEMENTS 2 STEP TESTING:
A second test, done 7 - 21 days after the first test, may be
required in certain situations and would be on the advice of TB
Control
A small percentage of persons will only react after a second test
or will react to a greater degree (so called boosting effect).
Intradermally ROUTE
1. History or documentation of previous positive reaction to tuberculin
testing (because of the severity of the reaction at the test site:
vesiculation, ulceration or necrosis)
CONTRAINDICATIONS
2. Documentation of previous active TB
3. History of an anaphylactic reaction to a previous test using
Tubersol or a similar product, or to any component of Tubersol
4. Individual with severe burns or eczema
5. Individuals with severe viral infections or live-virus vaccination in
the past 4 weeks (to avoid negative reactions).

Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 71




Tuberculin Skin Test (Mantoux) Tubersol
Supplier: sanofi pasteur
Tween 80 and phenol. VACCINE
COMPONENTS
PRECAUTIONS Do TB skin testing on the same day as MMR and /or varicella
and/or Zostavax and/or Yellow Fever vaccine, or delay TB skin
testing for 4 weeks

Read in 48 72 hours. EXPECTED
REACTIONS Possible redness, induration and blistering.
Measure only induration (raised) diameter in millimeters and
record this measurement. For general screening purposes, a
reading of 10 mm is considered positive (significant).
A result 5mm is considered positive for the following groups:
contacts of an active case of TB, immunocompromised
individuals, individuals with HIV infection, IVDUs, and individuals
with chest x-ray compatible with previous TB disease.
Refer for investigation if applicable
NOTE:
Pregnancy is not a contraindication to tuberculin testing
A previous Bacille Calmette-Guerin (BCG) vaccine is not a contraindication to tuberculin
testing




Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 72



Typhoid Vaccine (Salmonella Capsular Polysaccharide) (Inactivated) (Typhim Vi)
Supplier: sanofi pasteur
INDICATIONS Routine vaccination is not recommended in Canada.

Provided free to individuals 2 years of age with:
Ongoing household or intimate exposure to a typhoid carrier
when oral typhoid vaccine is contraindicated.

Recommended but not provided free to:
Travellers 2 years of age to countries where typhoid fever is
endemic or epidemic, or where sanitary conditions may be
doubtful and where travellers may be exposed to potentially
contaminated food and water.
Laboratory workers who frequently handle cultures of
Salmonella typhi.
INITIAL SERIESO Individuals 2 years of age: 0.5 ml IM
REINFORCEMENTS O Every 2 years under conditions of repeated or continued
exposure.
There are no data on the use of vaccine as a booster for
persons who received a primary series with one of the other
typhoid vaccines. However, a single dose of the vaccine at the
appropriate interval should re-establish protection.
History of anaphylactic reaction to a previous dose of any typhoid
vaccine, to any component of Typhim Vi, or to latex.
CONTRAINDICATIONS
Phenol, sodium dibasic phosphate, and sodium monobasic
phosphate.
VACCINE COMPONENTS
Administer to pregnant women only if clearly indicated. When
possible, delay Typhim Vi vaccine until after the 1
st
trimester.
PRECAUTIONS
Headache, malaise; pain and tenderness at injection site. ADVERSE EVENTS
O Immunization should be completed at least two weeks prior to potential exposure to S. typhi.
O The typhoid vaccines Vivotil , Typhim Vi, Typherix, and ViVAXIM are interchangeable
for children or adults at any scheduled dose, using the age-specific dosage for the particular
product.
Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 73



Typhoid Vaccine (Live Oral Attenuated Ty21a) in capsule presentation (Vivotil)
Supplier: Berna Biotech
INDICATIONS Routine vaccination is not recommended in Canada.

Provided free to:
Individuals 6 years of age with ongoing household or intimate
exposure to a typhoid carrier

Recommended but not provided free to:
Travelers 6 years of age to countries where typhoid fever is
endemic or epidemic, or where sanitary conditions may be
doubtful and where travellers may be exposed to potentially
contaminated food and water.
Laboratory workers who frequently handle cultures of Salmonella
typhi
INITIAL SERIES Adults and children 6 years of age:

Four doses: one vaccine capsule to be taken on alternate days (i.e.
days 1, 3, 5, and 7)O

To be taken one hour before a meal with a cold or lukewarm drink,
no warmer than 37C (body temperature).

The capsule should not be chewed and should be swallowed as soon
as possible after placing in the mouth.
REINFORCEMENTS Adults and children 6 years old every 4 years as required:
4 capsules each taken on alternate daysO
Orally ROUTE
1. History of anaphylactic reaction to a previous dose of any typhoid
vaccine or to any component of Ty21a (Vivotil ) or its enteric
coated capsule.
CONTRAINDICATIONS
2. Acute gastrointestinal illness (nausea and vomiting) or chronic
inflammatory bowel disease.
3. Immunocompromised persons (including HIV positive clients).
4. Pregnancy.
Ascorbic acid, lactose, sucrose, magnesium stearate, and amino
acids.
VACCINE

COMPONENTS

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 74



Typhoid Vaccine (Live Oral Attenuated Ty21a) in capsule presentation (Vivotil)
Supplier: Berna Biotech
PRECAUTIONS Yellow fever vaccine may be taken concurrently with oral typhoid
capsule vaccine.
Wait 24 hours after the completion of antibiotic treatment before
taking oral typhoid capsule vaccine.
Oral typhoid capsule vaccine and oral cholera liquid vaccine may
be taken together; however, concurrent administration impacts
malaria chemoprophylaxis. If oral typhoid capsules AND oral
cholera vaccines are taken concurrently, only mefloquine can be
taken on that same day.
If oral typhoid capsule vaccine is not taken together with oral
cholera vaccine, either chloroquine or mefloquine can be taken
concurrently with oral typhoid capsule vaccine.
If oral typhoid capsule vaccine and oral cholera liquid vaccine are
not taken together, a spacing of >8 hours must be adhered to in
order for gastric acidity to normalize.
Space 7 days between the last dose of oral typhoid capsule
vaccine and the first dose of proguanil.
Abdominal pain, diarrhea, nausea, vomiting, fever, skin rash on trunk
or extremities.
ADVERSE EVENTS
O If less than 2 days elapses between doses, repeat the dose that was given too early; the
next dose should be taken at the required 48-hour interval. Up to 3-4 days may elapse
between doses with no need to repeat the dose or series; however, subsequent dose(s)
must be taken at least 48 hours apart.
O The typhoid vaccines Vivotil, Typhim Vi, Typherix, and ViVAXIM are interchangeable
for children or adults at any scheduled dose, using the age-specific dosage for the

particular product.


Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2009
Page 75



Typhoid Vaccine (Salmonella Typhi Vi Capsular Polysaccharide)(Typherix)
Supplier: GlaxoSmithKline
INDICATIONS O Routine vaccination is not recommended in Canada.
Provided free to:
Individuals 2 years of age with ongoing household or intimate
exposure to a typhoid carrier

Recommended but not provided free to:
Travelers 2 years of age to countries where typhoid fever is
endemic or epidemic, or where sanitary conditions may be
doubtful and where travellers may be exposed to potentially
contaminated food and water.
Laboratory workers who frequently handle cultures of Salmonella
typhi
INITIAL SERIES Adults and children 2 years of age:
One dose: 0.5 ml IM
REINFORCEMENTSO Adults and children 2 years old every 2 years as required:
0.5 ml IM
History of anaphylactic reaction to a previous dose of any typhoid vaccine
or to any component of Typherix or to latex.
CONTRAINDICATIONS
VACCINE Sodium phosphate dihydrate, disodium phosphate dihydrate, phenol.
COMPONENTS
PRECAUTIONS An adequate immune response may not be achieved in clients receiving
immunosuppressive treatment or in clients who are
immunocompromised.
ADVERSE EVENTS Soreness, redness and swelling at the injection site
Headache and fever.
O The typhoid vaccines Vivotil, Typhim Vi, Typherix, and ViVAXIM are interchangeable
for children or adults at any scheduled dose, using the age-specific dosage for the particular
product.

Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 76


Varicella Zoster Immune Globulin (VariZIG)
Supplier: Cangene Corporation
INDICATIONS O O VariZIG is recommended for post-exposure prevention of varicella
in the following high-risk clients who cannot receive varicella vaccine
and who are at increased risk of severe varicella disease:
(1) Infants and children:
Immunocompromised clients (congenital or acquired) due to
treatment or disease, including some clients receiving high doses
of corticosteroidsO. Clients receiving monthly IGIV may not
require VariZIGO
Newborn infants whose mothers develop varicella disease 5
days before to 48 hours after delivery
Hematopoietic stem cell transplant (HSCT) recipients
Infants and children in neonatal or pediatric intensive care
settings, as determined by infectious disease/infection control
specialist.

(2) Adults:
Susceptible pregnant women
Immunocompromised adults (congenital or acquired) due to
disease or treatment, including clients receiving corticosteroid
treatment. Clients receiving regular monthly infusions of IGIV
may not require VariZIGO.
Hematopoietic stem cell transplant recipients
DOSE Give VariZIG IM as soon as possible, and within 96 hours of the
most recent exposure to varicella or zoster.

One vial containing 125 IU is given IM for each 10 kg of body weight
and is the minimum dose.
The maximum dose is 625 IU (i.e. 5 vials).

A vial containing 125 IU is reconstituted with 1.25 ml of the
sterile diluent. Diluent is only provided in 8.5 ml vials.

ROUTE The preferred site for the IM administration of VariZIG is the deltoid
area. Use the vastus lateralis in infants and children up to 5 years of
age.O
If a 2
nd
varicella exposure occurs more than 3 weeks after a dose of
VariZIG, another dose of VariZIG should be given.
REINFORCEMENTS

Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 77




Varicella Zoster Immune Globulin (VariZIG)
Supplier: Cangene Corporation
1. Regarding VariZIG and the administration of live vaccines (MMR
and Varicella) see
CONTRAINDICATIONS
Immune Globulin Preparations or Blood: Timing
Intervals For Vaccines Containing Live Measles, Mumps, Rubella,
or Varicella Virus













.
2. History of anaphylactic reaction following receipt of any human Ig
product, or a history of anaphylactic reaction to any component of
VariZIG
Glycine, polysorbate 80 and sodium phosphate.
VACCINE
COMPONENTS
Human Ig products are amongst the safest blood-derived products
available. The method of preparation includes one or more steps
that exclude or inactivate hepatitis B, C or HIV; therefore the risk
of transmission of these viruses is considered to be extremely low.
However, it is possible that unknown infectious agents may be
present in such products.
PRECAUTIONS
Persons with IgA deficiency have the potential for developing
antibodies to IgA and could have an anaphylactic reaction to
subsequent administration of blood products that contain IgA.
VariZIG should only be given to such persons if the expected
benefits outweigh the risks.
VariZIG contains no preservatives. Discard unused vial contents
SPECIAL
CONSIDERATIONS
O Contact the Blood Bank supervisor at the nearest hospital to obtain VariZIG
O Provide a written record to a client who receives any immune globulin product.
O A dose of 2 mg/kg/day of prednisone or equivalent, or > 20 mg. per day, particularly when
given for > 2 weeks.
O Patients receiving monthly infusions of 400mg/kg of IVIG and whose most recent infusion
was within 3 weeks of exposure do not require VariZIG
O See Immune Globulin Preparations (HBIg, Ig, TIg, VarIg, RabIg) for maximum volume to be
administered per site according to age.
Communicable Disease Control
Immunization Program
Section VII Biological Products
November 2010
Page 78


Varicella Vaccine (live attenuated viral) Varivax III and Varilrix
Supplier: Varivax III, Merck Frosst Canada; Varilrix, GlaxoSmithKline
INDICATIONSO
(1) All infants born on or after February 1, 2004, at 12 months of age (including infants with
a history of varicella disease occurring at < 12 months of age).

(2) Susceptible kindergarten and grade 6 students

(3) SusceptibleO children, adolescents, and adults at opportune health encounters. This
includes:
children and adults on low dose steroid therapy (< 2 mg prednisone/kg daily to a
maximum of 20 mg/day for < 2 weeks), and those taking inhaled or topical steroids
household contacts of immunocompromised individuals
health care workers
AND susceptible individuals at high risk of severe varicella disease:
Individuals with cystic fibrosis
Individuals on chronic salicylate therapy (those 18 years of age must be able to
discontinue it for 6 weeks post vaccination)

(4) SusceptibleO Immunocompromised CHILDREN and ADULTS.
Before vaccination of the following clients, receive approval from the appropriate physician (i.e.,
either the primary care physician most familiar with the clients current medical status or a
medical specialist). Refer to BC Communicable Disease Control Manual Chapter 2, Section III,
Subsection 1.4. Immunization With Live Vaccines


; use Referral Form for Varicella Vaccination
and use Varilrix ONLY:
with chronic kidney disease (and not receiving immunosuppressant therapy)
undergoing hemo or peritoneal dialysis (and not receiving immunosuppressant therapy)
with isolated immunodeficiency diseases:
IG deficiency
Neutrophil deficiency
Complement deficiency
AspleniaO
With acute lymphocytic leukemia in remission for at least 12 monthsO (2 doses 1-3
months apart)
With asymptomatic HIV, CD4 of 25% for age (2 doses 3 months apart)
Candidates for solid organ transplant (administer last dose 6 weeks before
transplantation)
2 years after HSCT (providing there is minimal immunosuppression and no graft vs
host disease)
3 months after being cured of a malignant disease and the end of immunosuppressive
treatment
1 month after completion of high doses (>2mg/kg or >20 mg/day) oral corticosteroid
therapy more than 14 days duration

Communicable Disease Control
Immunization Program
Section VII Biological Products
June 2009
Page 79


Varicella Vaccine (live attenuated viral)

INITIAL SERIES
12 months to 12 years of age: One dose: 0.5 ml SC
13 years of age: Two doses - dose 1: 0.5 ml SC
dose 2: 0.5 ml SC 4 weeks laterO
REINFORCEMENTS
Not indicated at this time
CONTRAINDICATIONS
1. Children/adults with:
T-cell or combined T-and B-cell immunodeficiencies (SCID)
Total lymphocyte count < 1.2 x 10
9
/L or presenting other evidence of lack of
cellular immune competence
Advanced HIV (AIDS)
Malignant solid tumours
Conditions requiring chronic immunosuppressive therapy
Acute lymphocytic leukemia (ALL) not in remission
Acute myelogenous leukemia (AML)
2. Adult solid organ transplant recipients
3. Children or adults with chronic inflammatory diseases (e.g., inflammatory bowel
disease, collagen-vascular disease) receiving significant immunosuppressive
therapy. However, they may be immunized at least 6 to 12 weeks after they have
completed or temporarily stopped the immunosuppressive therapy.
4. History of an anaphylactic reaction to a previous dose of any varicella vaccine, or to
any component of VarivaxIII or Varilrix.
5. Pregnancy. Women of childbearing age should avoid pregnancy for 1 month
following vaccination.
6. Active untreated TB.
7. For high risk/immunocompromised clients only - concurrent administration with
another live vaccine. Separate the administration of varicella vaccine and another
live vaccine by at least 4 weeks (expert opinion, BC Childrens Hospital, based on
concerns about adverse events with concurrent administration).
8. Recent administration of an immunoglobulin preparation or blood product. See
Immune Globulin Preparations or Blood: Timing Considerations for Vaccines
Containing Live Measles, Mumps, Rubella, or Varicella Virus



O
9. Family history of congenital immunodeficiency. See BC Communicable Disease
Control Manual, Section II B 2.0 ASSESSMENT FOR CONTRAINDICATIONS
AND PRECAUTIONS

Communicable Disease Control
Immunization Program
Section VII Biological Products
April 2010
Page 80


Varicella Vaccine (live attenuated viral)

VACCINE COMPONENTS
VarivaxIII: Hydrolyzed beef gelatin, neomycin, monosodium L-glutamate, sucrose,
sodium phosphate dibasic, urea, potassium phosphate monobasic, potassium chloride,
fetal bovine serum.
Varilrix: Amino acids, human albumin, lactose, neomycin sulphate, and polyalcohols.
PRECAUTIONS
Those 18 years of age should avoid taking salicylates for 6 weeks following
immunization.
Do TB skin testing on the same day as varicella immunization or delay TB skin
testing for 4 weeks.
Varicella immunization for immunocompetent clients should be given on the same
day or delayed until 4 weeks after administration of any other live vaccine.
ADVERSE EVENTS
Generally mild and include injection site reactions, non-injection site rash, and low-
grade fever.
SPECIAL CONSIDERATIONS
Administer vaccine immediately after reconstitution. Discard if not used within 30
minutes of reconstitution.
O Assess varicella susceptibility before immunization. A varicella susceptible
individual is defined as an individual:
with a history of varicella disease at <12 months of age
with no history of varicella disease at > 12 months of age, no history of herpes
zoster, and no history of varicella immunization.
For persons 13 years of age with negative or unknown history of prior varicella
infection, have serology done for VZV IgG (use BCCDC Laboratory Services
requisition).
O Whenever possible, vaccine should be given at least 14 days prior to elective
splenectomy, or if not possible, 14 or more days post-splenectomy. However,
vaccine is indicated whenever an individual with functional or anatomic asplenia is
identified.
O Total lymphocyte count must be 1.2 x 10
9
/L and client must not be receiving
radiation therapy at the time of immunization. If clients are still receiving
maintenance chemotherapy, it should be withheld for at least 1 week before to 1
week after immunization.
O Administer last dose of vaccine at least 6 weeks before transplantation, providing
the client is not receiving immunosuppressive treatment.
O Use same brand of varicella vaccine for dose 2. There is no data on the
interchangeability of Varivax III and Varilrix.
O Varicella-susceptible women who receive RhIg post-partum should be given the
first dose of varicella vaccine 2 months after delivery. Also at 2 months after
delivery, prior rubella-susceptible women should be tested for rubella immunity as
they should have been immunized against rubella immediately post-partum.

Communicable Disease Control
Immunization Program
Section VII Biological Products
May 2010
Page 81


Varicella Zoster Vaccine (live attenuated viral) (ZOSTAVAX)
Supplier: Merck Frosst
INDICATIONS Recommended but not currently provided free to:
Individuals > 60 years of age O
One dose: entire contents of vial (approximately 0.65ml) SC INITIAL SERIES


Not indicated at this time.O REINFORCEMENTS
1. History of anaphylactic reaction to a previous dose of varicella
zoster vaccine, or to any component of ZOSTAVAX
CONTRAINDICATIONS
2. Immune suppression related to diseaseO[e.g., malignant neoplasm
(including leukemia and lymphoma), HIV/AIDS]
3. Immune suppression related to therapy (e.g., high dose systemic
corticosteroid therapy, chemotherapy, radiation therapy, certain
medications for treatment of rheumatoid arthritis)
4. Congenital immunodeficiency
5. Active untreated tuberculosis
6. Pregnancy and breastfeeding

1. Delay immunization of individuals with severe acute illness until
recovery.
PRECAUTIONS
2. Varicella Zoster immunization should be given on the same day or
delayed until 4 weeks after administration of any other live vaccine.
3. Do TB skin testing on the same day as VZV immunization, or delay
TB skin testing for > 4 weeks.
4. ZOSTAVAX has not been studied in individuals who have
previously experienced an episode of herpes zoster. While these
individuals are at risk for further episodes, the efficacy of
ZOSTAVAX in this population is not known.
5. ZOSTAVAXand a pneumococcal polysaccharide 23 valent
vaccine should not be given at the same time due to the possibility
of an inferior immune response to ZOSTAVAX. Separate these
vaccines by 4 weeks.O
6. Antiviral medications active against VZV (i.e., acyclovir, famciclovir,
valacyclovir taken less than 2 days before or within 14 days after
immunization may decrease vaccine effectiveness.O
7. Delay ZOSTAVAX administration for 3 months after a dose of
intravenous immunoglobulin (IVIG).

Communicable Disease Control
Immunization Program
Section VII Biological Products
January 2010
Page 82


VACCINE
COMPONENTS
Neomycin, hydrolyzed porcine gelatin, sucrose, sodium chloride,
monosodium L-glutamate monohydrate, sodium phosphate dibasic,
potassium phosphate monobasic, potassium chloride, MRC-5 cells,
bovine calf serum.

ADVERSE EVENTS Local: Mild to moderate pain, redness, swelling, itchiness, varicella-like
rash at the injection site
Systemic: Headache, fever

SPECIAL
CONSIDERATIONS
1. ZOSTAVAX should be stored FROZEN at an average
temperature of -15C or colder until it is reconstituted for injection.
Do not freeze reconstituted vaccine. The diluent should be stored
separately at room temperature (20 to 25C) or in the refrigerator
(2 to 8C). Do not store the diluent in a freezer.
2. It is recommended that the vaccine be administered immediately
after reconstitution to minimize loss of potency. Discard
reconstituted vaccine if it is not used within 30 minutes.

O ZOSTAVAX is indicated for the prevention of herpes zoster in patients with prior chickenpox
infection. There is no known safety risk associated with vaccination of healthy individuals who are
varicella-susceptible. If individual is known to be serologically varicella susceptible, they should be
immunized with 2 doses of varicella vaccine.
O The efficacy of protection has not been assessed beyond 4 years and it is not known whether
booster doses of vaccine are beneficial.
O Consult clients medical specialist regarding the appropriateness of zoster vaccine
administration to persons whose immune status may be suppressed as the result of disease or
therapy (e.g., chronic renal disease/dialysis; solid organ transplant candidate;
hyposplenia/asplenia; 3 months after being cured of a malignant disease and the end of
immunosuppressive treatment).
O ZOSTAVAX and trivalent influenza vaccine may be given at the same time or be separated
by any interval. Co-administration of ZOSTAVAX with other vaccines has not been studied.
O Individuals who inadvertently receive systemic anti-viral therapy active against VZV within 2
days before and 14 days after ZOSTAVAX immunization may benefit from a second dose of
vaccine 42 days later and after discontinuing antiviral therapy.

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