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Components of
Hepatitis A Vaccine

 

Excipients Table
Allergens Table
Components Table

Indication

Active immunity against infection caused by hepatitis A

Proprietary Names

Havrix

Vaqta

Manufacturers

GlaxoSmithKline

Merck

Viability

Inactivated

Inactivated

Approved Ages

12 months and older

12 months or older

Dose

 

 

Adult

1 mL

1 mL

Pediatric

0.5 mL

0.5 mL

Route

Intramuscular

Intramuscular

Dose form

Suspension

Suspension

Appearance

Slightly turbid white suspension after shaking

Slightly opaque white suspension

Concentration

 

 

Adult

1440 ELU/mL

50 U/mL

Pediatric

720 ELU/0.5mL

25 U/0.5 mL

Preservatives

None

None

Adjuvants:

 

 

Adult

Aluminum hydroxide, 0.5 mg/mL

Aluminum hydroxide, 0.45 mg/mL

Pediatric

Aluminum hydroxide, 0.25/0.5 mL

Aluminum hydroxide, 0.225 mg/0.5 mL

Excipients

Amino acid supplement (0.3% w/v) with 0.05 mg/mL polysorbate-20,

Formalin, ≤0.1 mg/mL

MRC-5 cellular protein, ≤5 mcg

Nonviral protein, <0.1 mcg

DNA, <4 x 10-6 mcg

Formaldehyde,<0.8 mcg

Bovine albumin, <10-4 

Allergens

Neomycin sulfate, <40 ng/mL

Stopper of the vial contains dry natural rubber latex

 None

Media

MRC-5 human diploid cell culture

Human MRC-5 diploid fibroblasts

Packaging

Single dose vials (0.5 [360 and 720 EL.U] and 1 mL)and prefilled syringes

Single dose vials (0.5 mL and 1 mL) and prefilled syringes

Routine Storage

2 to 8C (36-46F)

Do not freeze

2 to 8C (36-46F)

Do not freeze

Package Insert Date

June 2013

November 2012

updated November 2013

 

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety