Page 15: Canadian Immunization Guide: Part 1 - Key Immunization Information

Contents of Immunizing Agents Available for Use in Canada

Updated: April 2017 

Introduction

The following tables provide a comprehensive list of contents of immunizing agents available in Canada. Table 1 lists contents of active vaccines and Table 2 lists contents of passive immunizing agents. Vaccine providers should consult the product label, product leaflet, or product monograph for current product information. Manufacturers provide evidence of vaccine safety and efficacy and receive authorization for the immunizing agent only when it is used in accordance with the product monograph available through Health Canada's Drug Product Database. Information about the vaccine manufacturer/distributor is available in vaccine-specific chapters in Part 4.

Contents of Immunizing Agents

In addition to the active component (antigen in case of vaccines or antibody in case of immune globulins), immunizing agents may contain additional ingredients such as adjuvants, preservatives, additives, and traces of other substances.

Adjuvants

An adjuvant is a substance that is added to a vaccine to enhance the resulting immune response and to extend the duration of B and T cell activation. An adjuvant allows a reduction in the amount of antigen per dose or the total number of doses needed to achieve immunity, and helps to improve the immune response in individuals with some degree of immune suppression (for example, the elderly). The adjuvants used in vaccines currently marketed in Canada are:

  • aluminum salts (aluminum hydroxide, aluminum phosphate, or aluminum hydroxyphosphate sulfate)
  • AS04 (3-O-desacyl-4'-monophosphoryl lipid A adsorbed onto aluminum [as hydroxide salt])
  • MF59 (oil-in-water emulsion composed of squalene as the oil phase, stabilized with the surfactants polysorbate 80 and sorbitan trioleate, in citrate buffer).

Preservatives

Chemicals (for example, thimerosal, phenol, 2-phenoxyethanol) may be added to vaccines to prevent serious infections which may result from bacterial or fungal contamination of the vaccine. Most vaccines available for use in Canada do not contain thimerosal.

Other contents of immunizing agents

Other substances that may be found in immunizing agents include:

  • Minute amounts of chemicals that are used during the production process, such as for the growth or purification of specific antigens or the inactivation of toxins. For example, antibiotics that prevent contamination during viral cell culture; egg or yeast proteins glycerol, serum, amino acids and enzymes that are needed for the growth of bacteria and viruses; and formaldehyde that is used to inactivate viruses and protein toxins.
  • Small amounts of chemicals that support product stability. For example, additives such as potassium or sodium salts, lactose, and polysorbate help control product acidity (pH) and maintain the quality of vaccine antigens.
Table 1: Types and Contents of Vaccines Available for Use in Canada
Brand name Route Vaccine type
(live; inactivated)
Immunogen Adjuvant Preservative Potential allergensTable 1 - Footnote 1 Other materials Abbreviation

Empty boxes indicate that there are no materials of relevance in the product.

Table 1 - Footnote 1

Any component in a vaccine may be a potential allergen. This table identifies most common allergens; adjuvants and preservatives may be potential allergens, but this is extremely rare.

Return to Table 1 footnote 1 referrer

Table 1 - Footnote 2

Multi-dose presentation only.

Return to Table 1 footnote 2 referrer

Table 1 - Footnote 3

Smallpox vaccine (dried) is not available for general use.

Return to Table 1 footnote 3 referrer

Table 1 - Footnote 4

Smallpox vaccine (frozen liquid) is not a Health Canada authorized product but will be released under Health Canada's Special Access Program if required.

Return to Table 1 footnote 4 referrer

Act-HIB® IM Inactivated Hib     Tetanus toxoid carrier protein
  • Sodium chloride
  • Sucrose
  • Trometamol
Hib
ADACEL® IM Inactivated
  • T
  • d
  • ap
Alum PE  
  • Formaldehyde
  • Glutaraldehyde
Tdap
ADACEL®-POLIO IM Inactivated
  • T
  • d
  • ap
  • IPV
Alum PE
  • Neomycin
  • Polymyxin B
  • Streptomycin
  • Bovine serum albumin
  • Formaldehyde
  • Glutaraldehyde
  • Polysorbate 80
  • Water for injection
Tdap-IPV
AGRIFLU® IM Inactivated Inf    
  • Egg protein
  • Kanamycin
  • Neomycin
  • Barium
  • Calcium chloride
  • Cetyltrimethylammonium bromide
  • Citrates
  • Disodium phosphate dihydrate
  • Formaldehyde
  • Magnesium chloride
  • Polysorbate 80
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Water for injection
TIV
AVAXIM® IM Inactivated HA Alum
  • PE
  • CH2O
Neomycin
  • Medium 199 Hanks
  • Polysorbate 80
  • Water for injection
HA
AVAXIM® Pediatric
BEXSERO® IM Inactivated Men B Alum   Latex in tip cap of syringe
  • Sodium chloride,
  • Histidine,
  • Sucrose,
  • Water for injections
  • Latex
4CMenB
BOOSTRIX® IM Inactivated
  • T
  • d
  • ap
Alum    
  • Formaldehyde
  • Glycine
  • Polysorbate 80
  • Sodium chloride
  • Water for injection
Tdap
BOOSTRIX®-POLIO IM Inactivated
  • T
  • d
  • ap
  • IPV
Alum  
  • Neomycin
  • Polymyxin B
  • Formaldehyde
  • Medium 199
  • Sodium chloride
  • Water for injection
Tdap-IPV
CERVARIX® IM Inactivated HPV AS04   Latex in plunger stopper of pre-filled syringe
  • Hydrated sodium chloride
  • Sodium dihydrogen phosphate dihydrate
  • Water for injection
HPV2
DUKORAL® Oral Inactivated
  • Chol
  • Ecol
     
  • Citric acid
  • Disodium hydrogen phosphate
  • Raspberry flavor
  • Saccharin sodium
  • Sodium carbonate
  • Sodium citrate
  • Sodium chloride
  • Sodium dihydrogen phosphate
  • Sodium hydrogen carbonate
  • Water for injection
Chol-Ecol-O
ENGERIX®-B IM Inactivated HB Alum
  • Disodium phosphate dihydrate
  • Polysorbate 20
  • Sodium chloride
  • Sodium dihydrogen phosphate dihydrate
HB
ENGERIX®-B Pediatric dose
FLUAD® IM Inactivated Inf MF59  
  • Egg protein
  • Kanamycin
  • Neomycin
  • Barium
  • Calcium chloride dihydrate
  • Cetyltrimethylammonium bromide
  • Disodium phosphate dihydrate
  • Formaldehyde
  • Magnesium chloride hexahydrate
  • Polysorbate 80
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Water for injection
TIV
Flulaval™ Tetra IM Inactivated Inf   Tm
  • Egg proteins
  • Thimerosal
  • α-tocopheryl hydrogen succinate
  • Ethanol
  • Formaldehyde
  • Phosphate buffered saline
  • Polysorbate 80
  • Sodium deoxycholate
  • Sucrose
QIV
FLUMIST® IN Live Inf    
  • Arginine
  • Egg protein
  • Gelatin
  • Gentamicin
  • Dibasic potassium phosphate
  • Monosodium glutamate
  • Monobasic potassium phosphate
  • Sucrose
LAIV
FLUVIRAL® IM Inactivated Inf   Tm
  • Egg protein
  • Thimerosal
  • Disodium hydrogen phosphate heptahydrate
  • Formaldehyde
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Sodium deoxycholate
  • Sucrose
  • Water for injection
TIV
FLUZONE® IM Inactivated Inf   TmTable 1 - Footnote 2
  • Formaldehyde
  • Gelatin
  • Sucrose
  • Triton® X-100
TIV
FLUZONE® HD IM Inactivated Inf    
  • Egg protein
  • Formaldehyde
    Octylphenol 2 ethoxylate
  • Sodium phosphate
  • Sodium chloride
TIV
FLUZONE® Quadrivalent IM Inactivated Inf   TmTable 1 - Footnote 2
  • Formaldehyde
  • Triton® X-100
  • Sodium phosphate-buffered isotonic sodium chloride solution
QIV
GARDASIL® IM Inactivated HPV Alum   Yeast protein
  • L-histidine
  • Polysorbate 80
  • Sodium borate
  • Sodium chloride
  • Water for injection
HPV4
GARDASIL® 9 IM Inactivated HPV Alum   Yeast protein
  • L-histidine
  • Polysorbate 80
  • Sodium borate
  • Sodium chloride
HPV9
HAVRIX® IM Inactivated HA Alum   Neomycin
  • Amino acids
  • Disodium phosphate
  • Formaldehyde
  • Monopotassium phosphate
  • Polysorbate 20
  • Potassium chloride
  • Sodium chloride
  • Water for injection
HA
HAVRIX® 720 JUNIOR
HIBERIX® IM Inactivated Hib     Tetanus toxoid carrier protein
  • Lactose
  • Sodium chloride
Hib
IMOVAX® Polio SC Inactivated IPV   PE
  • Neomycin
  • Polymyxin B
  • Streptomycin
  • Bovine serum
  • Formaldehyde
  • Medium 199 Hanks
  • Polysorbate 80
IPV
IMOVAX® Rabies IM Inactivated Rab    
  • Neomycin
  • Phenol red
  • Human albumin
  • Water for injection
HDCV
INFANRIX hexa® IM Inactivated
  • D
  • T
  • aP
  • HB
  • IPV
  • Hib
Alum  
  • Butyl in stopper
  • Neomycin
  • Polymyxin B
  • Yeast protein
  • Disodium phosphate
  • Formaldehyde
  • Glycine
  • Lactose
  • M199
  • Monopotassium phosphate
  • Polysorbate 20 and 80
  • Potassium chloride
  • Sodium chloride
  • Water for injection
DTaP-HB-IPV-Hib
INFANRIX®-IPV IM Inactivated
  • D
  • T
  • aP
  • IPV
   
  • Neomycin
  • Polymixin
  • Sodium chloride
  • Aluminum Salts
  • M 199
  • Water for injections
DTaP-IPV
INFANRIX®-IPV/Hib IM Inactivated
  • D
  • T
  • aP
  • IPV
  • Hib
Alum  
  • Neomycin sulphate
  • Polymixin sulphate
  • Lactose
  • Sodium chloride
  • M199
  • Water for injection
  • Residual formaldehyde
  • Polysorbate 80
  • Potassium chloride
  • Disodium phosphate, Monopotassium phosphate
  • Glycine
DTaP-IPV-Hib
INFLUVAC® IM Inactivated Inf    
  • Chick protein
  • Egg protein
  • Gentamicin
  • Calcium chloride dihydrate
  • Cetyltrimethylammonium bromide
  • Disodium phosphate dihydrate
  • Formaldehyde
  • Magnesium chloride hexahydrate
  • Polysorbate 80
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Water for injection
TIV
IXIARO® IM Inactivated JE Alum    
  • Disodium hydrogen phosphate
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Water for injection
JE
Menactra® IM Inactivated Men     Diphtheria toxoi carrier protein
  • Sodium chloride
  • Sodium phosphate dibasic (anhydrous)
  • Sodium phosphate monobasic
  • Water for injection
Men-C-ACYW-DT
Menjugate® IM Inactivated Men Alum  
  • Latex in tip cap of syringe
  • Diphtheria CRM197 toxoid carrier protein
  • Disodium phosphate heptahydrate
  • Mannitol
  • Sodium chloride
  • Sodium dihydrogen phosphate monohydrate
  • Water for injection
Men-C-C-CRM
Menveo™ IM Inactivated Men     Diphtheria CRM197 toxoid carrier protein
  • Disodium hydrogen phosphate bihydrate
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Sodium dihydrogen phosphate monohydrate
  • Sucrose
  • Water for injection
Men-C-ACYW-CRM
M-M-R® II SC Live
  • Meas
  • Mumps
  • R
   
  • Neomycin
  • Phenol red
  • Porcine gelatin
  • Residual components of chick embryo cell cultures
  • Fetal bovine serum
  • Medium 199 with Hank's salts
  • Minimum essential medium (Eagle)
  • Monosodium L-glutamate monohydrate
  • Potassium phosphate dibasic (anhydrous)
  • Potassium phosphate monobasic
  • Recombinant human albumin
  • Sodium bicarbonate
  • Sodium phosphate dibasic (anhydrous)
  • Sodium phosphate monobasic
  • Sorbitol
  • Sucrose
  • Water for injection
MMR
NeisVac-C® IM Inactivated Men Alum   Tetanus toxoid carrier protein Sodium chloride Men-C-C-TT
NIMENRIX® IM Inactivated Men     Tetanus toxoid carrier protein
  • Sucrose
  • Trometamol
  • Sodium chloride
  • Water for injection
Men-C-ACYW-TT
PEDIACEL® IM Inactivated
  • D
  • T
  • aP
  • -IPV
  • Hib
Alum PE
  • Neomycin
  • Polymyxin B
  • Streptomycin
  • Bovine serum albumin
  • Formaldehyde
  • Glutaraldehyde
  • Polysorbate 80
DTaP-IPV-Hib
PNEUMOVAX® 23 SC/IM Inactivated Pneu   P  
  • Sodium chloride
  • Water for injection
Pneu-P-23
Prevnar® 13 IM Inactivated Pneu Alum   Diphtheria CRM197 toxoid carrier protein
  • Polysorbate 80
  • Sodium chloride
  • Succinic acid
  • Water for injection
Pneu-C-13
PRIORIX® SC/IM Live
  • Meas
  • Mumps
  • R
   
  • Egg protein
  • Neomycin
  • Amino acids
  • Lactose
  • Mannitol
  • Sorbitol
  • Water for injection
MMR
PRIORIX-TETRA® SC/IM Live
  • Meas
  • Mumps
  • R
  • Var
   
  • Egg protein
  • Neomycin
  • Amino Acids
  • Lactose
  • Mannitol
  • Sorbitol
  • Water for injection
MMRV
PROQUAD™ SC Live
  • Meas
  • Mumps
  • R
  • Var
   
  • Gelatin
  • Neomycin
  • Sucrose
  • Urea
  • Sodium chloride
  • Sorbitol
  • Monosodium L-glutamate
  • Sodium phosphate
  • Human albumin
MMRV
QUADRACEL® IM Inactivated
  • D
  • T
  • aP
  • IPV
Alum PE
  • Neomycin
  • Polymyxin B
  • Bovine serum albumin
  • Formaldehyde
  • Glutaraldehyde
  • Polysorbate 80
DTaP-IPV
RabAvert® IM Inactivated Rab    
  • Amphotericin B
  • Chick protein
  • Chlortetracycline
  • Neomycin
  • Polygeline (gelatin)
  • Egg protein
Human serum albumin PCECV
RECOMBIVAX HB® IM Inactivated HB Alum  
  • Latex in vial stopper
  • Yeast protein
  • Formaldehyde
  • Sodium borate
  • Sodium chloride
  • Water for injection
HB
ROTARIX® Oral Live Rot      
  • Disodium adipate
  • DNA fragments from porcine circovirus 1
  • Dulbecco's Modified Eagle Medium
  • Sterile water
  • Sucrose
Rot-1
RotaTeq® Oral Live Rot      
  • DNA fragments from porcine circoviruses 1 and 2
  • Fetal bovine serum
  • Polysorbate 80
  • Residual protein from cell culture
  • Sodium citrate dihydrate
  • Sodium hydroxide
  • Sodium phosphate monobasic monohydrate
  • Sucrose
Rot-5
Smallpox (dried)Table 1 - Footnote 3 ID Live Vaccinia    
  • Latex in stopper of vaccine vial
  • Neomycin
  • Streptomycin
  • Bovine tissue (trace)
  • Glycerol
  • McIlvaine buffer
  • Phenol
Sma
Smallpox (frozen)Table 1 - Footnote 4               Sma
SYNFLORIX® IM Inactivated Pneu Alum  
  • Latex in syringe components
  • Diphtheria toxoid carrier protein
  • Tetanus toxoid carrier protein
  • Non-typeable Haemophilus influenzae protein D carrier protein
  • Sodium chloride
  • Water for injection
Pneu-C-10
Td ADSORBED IM Inactivated
  • T
  • d
Alum PE  
  • Formaldehyde
  • Sodium chloride
  • Water for injection
Td
Td POLIO ADSORBED IM Inactivated
  • T
  • d
  • IPV
Alum PE
  • Neomycin
  • Polymyxin B
  • Bovine serum albumin
  • Formaldehyde
  • Polysorbate 80
Td-IPV
TWINRIX® IM Inactivated
  • HA
  • HB
Alum  
  • Neomycin
  • Yeast protein
  • Amino acids
  • Formaldehyde
  • Polysorbate 20
  • Sodium chloride
  • Water for injection
HAHB
TWINRIX® Junior
TYPHERIX® IM Inactivated Typh   P  
  • Disodium phosphate dihydrate
  • Sodium chloride
  • Sodium phosphate dihydrate
  • Water for injection
Typh-I
TYPHIM Vi® IM Inactivated Typh   P   Isotonic buffer solution Typh-I
VAQTA® IM Inactivated HA Alum  
  • Latex in vial stopper
  • Neomycin
  • Bovine albumin
  • DNA
  • Formaldehyde
  • Residual protein from cell culture
  • Sodium borate
  • Sodium chloride
  • Water for injection
HA
VARILRIX® SC Live Var     Neomycin
  • Amino acids
  • Human albumin
  • Lactose
  • Polyalcohols
  • Water for injection
Var
VARIVAX® III SC Live Var    
  • Neomycin
  • Porcine gelatin
  • Fetal bovine serum
  • Monosodium L-glutamate
  • Potassium chloride
  • Potassium phosphate monobasic
  • Residual protein from cell culture
  • Sodium chloride
  • Sodium phosphate dibasic
  • Sucrose
  • Urea
  • Water for injection
Var
VAXIGRIP® IM Inactivated Inf   TmTable 1 - Footnote 2
  • Disodium phosphate dihydrate
  • Formaldehyde
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Sucrose
  • Triton® X-100
TIV
ViVAXIM® IM Inactivated Typh (HA) Alum
  • PE
  • CH2O
Neomycin
  • Disodium phosphate dihydrate
  • Medium 199 Hanks
  • Polysorbate 80
  • Sodium chloride
  • Sodium dihydrogen phosphate dihydrate
  • Water for injection
HA-Typh-I
Vivotif® Oral Live Typh     Gelatin
  • Amino acid mixture
  • Ascorbic acid
  • Dibutyl phthalate
  • Diethyl phthalate
  • Erythrosine FD+C red 3
  • Ethylene glycol
  • Hydroxypropylcellulose-phthalate
  • Lactose
  • Magnesium stearate
  • Red iron oxide
  • Sucrose
  • Titanium dioxide
  • Yellow iron oxide
Typh-O
YF-VAX® SC Live YF    
  • Chick protein
  • Egg protein
  • Gelatin
  • Latex in stopper of diluent vial
  • Sodium chloride
  • Sorbitol
YF
ZOSTAVAX® SC Live Zos    
  • Neomycin
  • Porcine gelatin
  • Bovine calf serum
  • Monosodium L-glutamate monohydrate
  • Potassium chloride
  • Potassium phosphate monobasic
  • Residual protein from cell culture
  • Sodium chloride
  • Sucrose
  • Sodium phosphate dibasic
  • Water for injection
HZV

Abbreviations

Route-
ID
intradermal
IM
intramuscular
IN
intranasal
SC
subcutaneous
Immunogen-
aP
acellular pertussis
ap
acellular pertussis (reduced)
BCG
Bacillus Calmette-Guérin
Chol
cholera
D
diphtheria
d
diphtheria (reduced)
Ecol
enterotoxigenic Escherichia coli
Hib
Haemophilus influenzae type b
HA
hepatitis A
HB
hepatitis B
HPV
human papillomavirus
Inf
influenza
IPV
inactivated poliomyelitis
JE
Japanese encephalitis
Men
meningococcus
Men B
Neisseria meningitidis Serogroup B protein
Meas
measles
Mumps
mumps
Pneu
pneumococcus
Rab
rabies
Rot
rotavirus
R
rubella
T
tetanus
Typh
typhoid
Var
varicella
YF
yellow fever
Zos
herpes zoster
Adjuvant-
Alum
aluminum-containing adjuvant
AS04
3-O-desacyl-4'-monophosphoryl lipid A adsorbed onto aluminum (as hydroxide salt)
MF59
squalene, polysorbate 80, sorbitan trioleate, sodium citrate, citric acid, water for injection
Preservative-
CH 2O
formaldehyde
P
phenol
PE
2-phenoxyethanol
Tm
thimerosal
Table 2: Types and Contents of Passive Immunizing Agents Available for Use in Canada
Brand name Route Passive immunizing agent type Protects against or treats Preservative Potential allergens Other materials Abbreviation

Empty boxes indicate that there are no materials of relevance in the product.

ANTIDIPHTHERIA SERUM IV Antitoxin D P Equine protein Sodium chloride DAtx
Cytogam® IV Immune globulin CMV    
  • Sucrose
  • Human albumin
CMVIg
GamaSTAN® S/D IM Immune globulin
  • HA
  • Meas
   
  • Glycine
  • Human plasma protein
  • Sodium chloride
  • Water for injection
Ig
HepaGam B® IM Immune globulin HB    
  • Human plasma protein
  • Maltose
  • Polysorbate 80
  • Tri-n-butyl phosphate
  • Triton® X-100
HBIg
HyperHEP B® S/D IM Immune globulin HB    
  • Glycine
  • Human plasma protein
  • Sodium chloride
  • Water for injection
HBIg
HYPERRAB™ S/D IM/ -local Immune globulin Rab    
  • Glycine
  • Human plasma protein
  • Sodium chloride
  • Water for injection
RabIg
HYPERTET® S/D IM Immune globulin Tet    
  • Glycine
  • Human plasma protein
  • Sodium chloride
  • Water for injection
TIg
IMOGAM® Rabies Pasteurized IM/ -local Immune globulin Rab   Latex in vial stopper
  • Glycine
  • Human plasma protein
  • Hydrochloric acid
  • Sodium hydroxide
  • Sodium chloride
RabIg
SYNAGIS® (palivizumab) IM Humanized monoclonal antibody RSV    
  • Glycine
  • Histidine
  • Mannitol
  • Water for injection
RSVAb
CNJ-016™ IV Immune globulin Vaccinia    
  • Maltose
  • Polysorbate 80
  • Water for injection
VIG
VariZIG™ IV/ IM Immune globulin Var    
  • Glycine
  • Human plasma protein
  • Polysorbate 80
  • Sodium chloride
  • Sodium phosphate
  • Tri-n-butyl phosphate
  • Triton® X-100
VarIg

Abbreviations:

Route-
IM
intramuscular
IV
intravenous
Protects against or treats-
D
diphtheria
HA
hepatitis A
HB
hepatitis B
Meas
measles
R
rubella
Rab:
rabies
RSV
respiratory syncytial virus
T
tetanus
Var
varicella
Preservative-
P
phenol

Selected References

  • Keith LS, Jones DE, Chou C. Aluminum toxicokinetics regarding infant diet and vaccinations. Vaccine 2002;20:S13-17.
  • Offit PA, Jew RK. Addressing parents' concerns: Do vaccines contain harmful preservatives, adjuvants, additives, or residuals? Pediatrics 2003;112:1394-97.
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