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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

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Excipients per 0.5 mL

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Allergens Table
Components Table

Excipient

Type

Vaccine Name

Vaccine Type

Amount

2-Phenoxyethanol

Stabilizer

Adacel

Tdap

not as a preservative

2-Phenoxyethanol

Stabilizer

Daptacel

DTaP

3.3 mg (0.6% v/v) (not as a preservative)

2-Phenoxyethanol

Preservative

IPOL

Polio

0.5% (as a preservative)

2-Phenoxyethanol

Stabilizer

Pentacel

DTaP+IPV+Hib

3.3 mg (0.65 v/v) (not as a preservative)

3-O-desacyl-4’-monophosphoryl lipid A (MPL)

Adjuvant

Cervarix

HPV

50 mcg

Albumin

Stabilizer

Imovax

Rabies

<100 mg

Albumin, Bovine

Stabilizer

Ixiaro

Japanese Encephalitis

≤100 ng/mL

Albumin, Bovine

Stabilizer

Pentacel

DTaP+IPV+Hib

≤50 ng residual

Albumin, Bovine

Stabilizer

Vaqta

HepA

<10-4 mcg

Albumin, Calf Serum

Stabilizer

Kinrix

DTaP+IPV

VERO cell culture growth

Albumin, Calf Serum

Stabilizer

Zostavax

Zoster

trace amounts

Albumin, Calf Serum Protein

Stabilizer

IPOL

IPV

< 1 ppm

Albumin, Calf Serum Protein

Stabilizer

Pediarix

DTaP+HepB+IPV

Ingredient in growth medium

Albumin, Calf Serum Protein

Stabilizer

Pentacel

DTaP+IPV+Hib

supplements CMRL 1969 medium

Albumin, Calf Serum Protein

Stabilizer

ProQuad

MMRV

0.5 mcg

Albumin, Egg (Ovalbumin)

Residual Medium

Afluria

Influenza

≤1 mcg

Albumin, Egg (Ovalbumin)

Residual Medium

Fluarix

Influenza

≤0.05 mcg

Albumin, Egg (Ovalbumin)

Residual Medium

Flulaval

Influenza

≤ 1 mcg

Albumin, Egg (Ovalbumin)

Residual Medium

Fluvirin

Influenza

≤1 mcg

Albumin, Egg (Ovalbumin)

Residual Medium

FluZone

Influenza

limited quantity

Albumin, Egg (Ovalbumin)

Residual Medium

RabAvert

Rabies

< 3 ng/dose

Albumin, Fetal Bovine Serum

Stabilizer

MMR-II

MMR

<1 ppm

Albumin, Fetal Bovine Serum

Stabilizer

RotaTeq

Rotavirus

trace amounts

Albumin, Fetal Bovine Serum

Stabilizer

Varivax

Varicella

trace amounts

Albumin, Human Serum

Diluent/Stabilizer

ACAM2000

Smallpox

2%

Albumin, Human Serum

Diluent/Stabilizer

MMR-II

MMR

≤0.3 mg

Albumin, Human Serum

Diluent/Stabilizer

ProQuad

MMRV

0.31 mg

Albumin, Human Serum

Diluent/Stabilizer

RabAvert

Rabies

<0.3 mg

Alcohol

Purification

Pneumovax 23

Pneumococcal 23-valent

Amount not specified in Package Insert

Aluminum

Adjuvant

Adacel

Tdap

0.33 mg

Aluminum

Adjuvant

BioThrax

Anthrax

1.2 mg/mL

Aluminum

Adjuvant

Boostrix

Tdap

≤ 0.39 mg

Aluminum

Adjuvant

Cervarix

HPV

0.5 mg aluminum hydroxide

Aluminum

Adjuvant

Comvax

Hib+HepB

225 mcg as amorphous aluminum hydroxyphosphate sulfate

Aluminum

Adjuvant

Daptacel

DTaP

0.33 mg

Aluminum

Adjuvant

Decavac

Td

≤ 0.28 mg, as aluminum potassium sulfate adjuvant

Aluminum

Adjuvant

DT

DT

≤0.17 mg

Aluminum

Adjuvant

Engerix-B

HepB

0.5 mg/mL as aluminum hydroxide

Aluminum

Adjuvant

Gardasil

HPV

225 mcg as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant

Aluminum

Adjuvant

Havrix

HepA

0.5 mg/mL as aluminum hydroxide

Aluminum

Adjuvant

Infanrix

DTaP

≤ 0.625 mg as aluminum hydroxide

Aluminum

Adjuvant

Ixiaro

Japanese Encephalitis

250 mcg aluminum hydroxide

Aluminum

Adjuvant

Kinrix

DTaP+IPV

≤0.6 mg aluminum hyroxide

Aluminum

Adjuvant

Pediarix

DTaP+HepB+IPV

≤ 0.85 mg

Aluminum

Adjuvant

PedvaxHIB

Hib+HepB

225 mcg amorphous aluminum hydroxyphosphate sulfate

Aluminum

Adjuvant

Pentacel

DTaP+IPV+Hib

0.33 mg

Aluminum

Adjuvant

Prevnar

Pneumococcal 7-valent

0.125 mg

Aluminum

Adjuvant

Prevnar 13

Pneumococcal 13-valent

0.125 mg

Aluminum

Adjuvant

Recombivax HB

HepB

0.5 mg/mL

Aluminum

Adjuvant

Td

Td

≤0.53 mg

Aluminum

Adjuvant

Tripedia

DTaP

0.170 mg

Aluminum

Adjuvant

Twinrix

HepA+HepB

0.45 mg as aluminum phosphate and aluminum hydroxide

Aluminum

Adjuvant

Vaqta

HepA

0.45 mg/mL  (0.225 mg in ped dose)

Aluminum Potassium Sulfate

Adjuvant

Decavac

Td

Amount not specified in Package Insert

Amino Acid

Medium Nutrient

BioThrax

Anthrax

in growth medium

Amino Acid

Medium Nutrient

Cervarix

HPV

in growth medium

Amino Acid

Medium Nutrient

Comvax

Hib+HepB

Amount not specified in Package Insert

Amino Acid

Medium Nutrient

FluMist

Influenza

2.42 mg/dose Arginine

Amino Acid

Medium Nutrient

Gardasil

HPV

in growth medium

Amino Acid

Medium Nutrient

Havrix

HepA

0.3% in a phosphate-buffered saline solution

Amino Acid

Medium Nutrient

Menveo

Meningococcal

Ingredient in growth medium

Amino Acid

Medium Nutrient

MMR-II

MMR

Ingredient in growth medium (Medium 199)

Amino Acid

Medium Nutrient

PedvaxHIB

Hib+HepB

Amount not specified in Package Insert

Amino Acid

Medium Nutrient

Recombivax HB

HepB

Ingredient of fermentation medium

Amino Acid

Medium Nutrient

Rotarix

Rotavirus

in DMEM (Dulbecco's Modified Eagle Medium)

Amino Acid

Medium Nutrient

Twinrix

HepA+HepB

Amount not specified in Package Insert

Amino Acid

Medium Nutrient

Vivotif

Typhoid

1.4-7 mg/capsule

Ammonium Sulfate

Protein Purifier

ActHIB

Hib

purification

Ammonium Sulfate

Protein Purifier

Adacel

Tdap

purification

Ammonium Sulfate

Protein Purifier

Decavac

Td

purification

Ammonium Sulfate

Protein Purifier

Menactra

Meningococcal

purification

Ammonium Sulfate

Protein Purifier

Prevnar

Pneumococcal 7-valent

Ingredient in purification

Ammonium Sulfate

Protein Purifier

Prevnar 13

Pneumococcal 13-valent

Ingredient in purification

Ammonium Sulfate

Protein Purifier

Td

Td

purification

Ammonium Sulfate

Protein Purifier

Tripedia

DTaP

purification

Amphotericin B

Antimicrobial

RabAvert

Rabies

<2 ng

Ascorbic Acid

Anitoxidant

Vivotif

Typhoid

1-5 mg/capsule

Benzethonium Chloride

Preservative

BioThrax

Anthrax

25 mcg/mL

Beta-Propiolactone

Viral Inactivator

Afluria

Influenza

< 25 ng

Beta-Propiolactone

Viral Inactivator

Fluvirin

Influenza

≤ 5 mcg

Beta-Propiolactone

Viral Inactivator

Imovax

Rabies

Amount not specified in Package Insert

Beta-Propiolactone

Viral Inactivator

RabAvert

Rabies

Amount not specified in Package Insert

Bovine Casein

Medium Nutrient

Boostrix

Tdap

Amount not specified in Package Insert

Bovine Casein

Medium Nutrient

Infanrix

DTaP

12.2-18.3 ng/mL1

Bovine Casein

Medium Nutrient

Kinrix

DTaP+IPV

Ingredient in Latham medium

Bovine Casein

Medium Nutrient

Pediarix

DTaP+HepB+IPV

Ingredient of Latham medium

Bovine Casein

Medium Nutrient

Vivotif

Typhoid

in medium

Bovine Extract

Medium Nutrient

Boostrix

Tdap

Amount not specified in Package Insert

Bovine Extract

Medium Nutrient

Decavac

Td

Amount not specified in Package Insert

Bovine Extract

Medium Nutrient

DT

DT

Amount not specified in Package Insert

Bovine Extract

Stabilizer

Infanrix

DTaP

Ingredient in Fenton medium

Bovine Extract

Stabilizer

Kinrix

DTaP+IPV

Ingredient in Fenton medium

Bovine Extract

Stabilizer

Pediarix

DTaP+HepB+IPV

Ingredient of Fenton medium

Bovine Extract

Stabilizer

Td

Td

Ingredient in Mueller's media

Bovine Extract

Stabilizer

Tripedia

DTaP

Ingredient in medium

Bovine, Casamino Acid

Stabilizer

Adacel

Tdap

8.1-17.3 ng/mL[i]

Bovine, Casamino Acid

Stabilizer

Daptacel

DTaP

10 ng/mL1

Bovine, Casamino Acid

Stabilizer

Pentacel

DTaP+IPV+Hib

Ingredient of Mueller-Miller medium

Bovine, Casamino Acid

Stabilizer

Prevnar

Pneumococcal 7-valent

Ingredient of growth medium

Bovine, Casamino Acid

Stabilizer

Prevnar 13

Pneumococcal 13-valent

Ingredient in growth medium

Calcium Carbonate

Buffer

Rotarix

Rotavirus

Ingredient in diluent

Calcium Chloride

Medium Nutrient

Afluria

Influenza

1.5 mcg

Calcium Chloride

Medium Nutrient

Rotarix

Rotavirus

in DMEM (Dulbecco’s Modified Eagle Medium)

Carbohydrates

Medium Nutrient

Gardasil

HPV

in fermentation medium

Cetyltrimethylammonium Bromide (CTAB)

Protein Purifier

Agriflu

Influenza

≤12 mcg

Chick Embryo

Residual Medium

MMR-II

MMR

No intact cells (may have trace residual protein)

Chick Embryo

Residual Medium

ProQuad

MMRV

No intact cells (may have trace residual protein)

Chick fibroblasts

Protein Purifier

RabAvert

Rabies

Growth medium

Chlortetracycline

Antimicrobial

RabAvert

Rabies

1 mcg

Dextrose

Medium Nutrient

Comvax

Hib+HepB

Amount not specified in Package Insert

Dextrose

Medium Nutrient

Recombivax HB

HepB

Ingredient of fermentation medium

Dextrose

Medium Nutrient

TwinRix

HepA+HepB

Amount not specified in Package Insert

Dextrose

Medium Nutrient

Vivotif

Typhoid

in medium

D-glucose

Medium Nutrient

Rotarix

Rotavirus

in DMEM

Dimethyl-beta-cyclodextrin

Medium Nutrient

Adacel

Tdap

Amount not specified in Package Insert

Dimethyl-beta-cyclodextrin

Medium Nutrient

Daptacel

DTaP

Amount not specified in Package Insert

Dimethyl-beta-cyclodextrin

Medium Nutrient

Pentacel

DTaP+IPV+Hib

Ingredient of Stainer-Scholte medium

DNA

Residual Medium

Ixiaro

Japanese Encephalitis

≤200 pg/mL ('host cell DNA')

DNA

Residual Medium

ProQuad

MMRV

residual component of MRC-5 cells

DNA

Residual Medium

Vaqta

HepA

< 4 x 10–6 mcg

DNA

Residual Medium

Varivax

Varicella

residual component of MRC-5 cells

DNA

Residual Medium

Zostavax

Zoster

residual component of MRC-5 cells

Egg Protein

Residual Medium

Agriflu

Influenza

<0.4 mcg (residual amounts)

Egg, Allantoic fluid

Residual Medium

FluMist

Influenza

Amount not specified in Package Insert

Ethylene diamine-Tetracetic Acid Sodium (EDTA)

Preservative

FluMist

Influenza

added to the H3N2 dilution buffer

Ethylene diamine-Tetracetic Acid Sodium (EDTA)

Preservative

RabAvert

Rabies

0.3 mg sodium EDTA

Ethylene diamine-Tetracetic Acid Sodium (EDTA)

Preservative

Varivax

Varicella

trace amounts

Ferric (III) Nitrate

Medium Nutrient

Rotarix

Rotavirus

in DMEM (Dulbecco’s Modified Eagle Medium)

Formaldehyde

Inactivating Agent

ActHIB

Hib

<0.5 mcg

Formaldehyde

Inactivating Agent

Adacel

Tdap

≤ 5 mcg

Formaldehyde

Inactivating Agent

Agriflu

Influenza

≤ 10 mcg

Formaldehyde

Inactivating Agent

BioThrax

Anthrax

100 mg/mL (added as a preservative)

Formaldehyde

Inactivating Agent

Boostrix

Tdap

≤ 100 mcg (residual)

Formaldehyde

Inactivating Agent

Comvax

Hib+HepB

≤ 0.0004% (w/v) residual

Formaldehyde

Inactivating Agent

Daptacel

DTaP

≤ 5 mcg (residual)

Formaldehyde

Inactivating Agent

Decavac

Td

≤ 100 mcg (residual)

Formaldehyde

Inactivating Agent

DT

DT

< 0.02%

Formaldehyde

Inactivating Agent

Fluarix

Influenza

≤ 5 mcg

Formaldehyde

Inactivating Agent

Flulaval

Influenza

≤ 25 mcg

Formaldehyde

Inactivating Agent

FluZone

Influenza

≤ 100 mcg/.5mL in Fluzone
≤ 20 mcg in Fluzone Intradermal

Formaldehyde

Inactivating Agent

Havrix

HepA

≤0.1 mg/mL formalin

Formaldehyde

Inactivating Agent

Hiberix

Hib

<0.5 mcg (residual)

Formaldehyde

Inactivating Agent

Infanrix

DTaP

≤ 100 mcg (residual)

Formaldehyde

Inactivating Agent

IPOL

Polio

≤ 0.02%

Formaldehyde

Inactivating Agent

Ixiaro

Japanese Encephalitis

≤ 200 pmm

Formaldehyde

Inactivating Agent

JE-Vax

Japanese Encephalitis

<200 mcg

Formaldehyde

Inactivating Agent

Kinrix

DTaP+IPV

≤ 100 mcg (residual)

Formaldehyde

Inactivating Agent

Menactra

Meningococcal

<2.66 mcg

Formaldehyde

Inactivating Agent

Menveo

Meningococcal

≤ 0.3 mcg

Formaldehyde

Inactivating Agent

Pediarix

DTaP+HepB+IPV

≤ 100 mcg (residual)

Formaldehyde

Inactivating Agent

Pentacel

DTaP+IPV+Hib

5 mcg (residual)

Formaldehyde

Inactivating Agent