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

Contents of Immunizing Agents Available for Use in Canada

Last partial content update (see Table of Updates): April 2017

Introduction
Contents of Immunizing Agents
Table 1: Types and Contents of Vaccines Available for Use in Canada
Table 2: Types and Contents of Passive Immunizing Agents Available for Use in Canada

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 allergens^{Table 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	IM	Inactivated	HA	Alum	PE CH₂O	Neomycin	Medium 199 Hanks Polysorbate 80 Water for injection	HA
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	Tm^{Table 1 - Footnote 2} PE^{Table 1 - Footnote 2}	Yeast protein Thimerosal^{Table 1 - Footnote 2}	Disodium phosphate dihydrate Polysorbate 20 Sodium chloride Sodium dihydrogen phosphate dihydrate	HB
ENGERIX^®-B Pediatric dose	IM	Inactivated	HB	Alum	Tm^{Table 1 - Footnote 2} PE^{Table 1 - Footnote 2}	Yeast protein Thimerosal^{Table 1 - Footnote 2}		HB
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		Tm^{Table 1 - Footnote 2}	Egg protein Gelatin Neomycin Thimerosal^{Table 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		Tm^{Table 1 - Footnote 2}	Egg protein Thimerosal^{Table 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	IM	Inactivated	HA	Alum		Neomycin		HA
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 Chick protein	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	IM	Inactivated	HA HB	Alum		Neomycin Yeast protein		HAHB
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		Tm^{Table 1 - Footnote 2}	Egg protein Neomycin Thimerosal^{Table 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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Page 15: Canadian Immunization Guide: Part 1 - Key Immunization Information

Contents of Immunizing Agents Available for Use in Canada

Introduction

Contents of Immunizing Agents

Adjuvants

Preservatives

Other contents of immunizing agents

Abbreviations

Route-

Immunogen-

Adjuvant-

Preservative-

Abbreviations:

Route-

Protects against or treats-

Preservative-

Selected References

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