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Components of
Japanese Encephalitis Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

Induction of active immunity against the causative virus among people who plan to reside in or travel to areas where JE is endemic or epidemic during a transmission season.

For active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV) in persons 17 years of age and older.

Proprietary Name

JE-VAX

IXIARO

Manufacturer

Biken, distributed by sanofi pasteur

Intercell Biomedical, distributed by Novartis

Viability

Inactivated

Inactivated

Microorganism

Single-stranded RNA virus, family Flaviviridae

Japanese encephalitis virus (JEV)

 

Dose

>3 years: 1.0 mL (3 doses at 0,7,30 days; abbreviated schedule 0,7,14 days)

1-3 years: 0.5 mL dose at 0,7,30 days; booster dose can be given after 2 years

0.5 mL (2 doses 28 days apart)

Route

Subcutaneous

Subcutaneous

Ages

1 year and older

2 months and older

Appearance

White caked powder

After reconstitution, colorless, transparent liquid

White, opaque, non-uniform suspension which becomes homogeneous upon shaking.

Concentration

Nitrogen, 2-3 mcg/dose

Preservatives

Thimerosal, 0.007%

None

Adjuvant

None

Excipients

Formaldehyde, < 100 mcg

Formaldehyde, ≤ 200 ppm

Bovine serum albumin,  ≤ 100 ng/mL

Host cell DNA,  ≤ 200 pg/mL

Sodium metabisulphite, 200 ppm

Host cell proteins,  ≤ 300 ng/mL

Protamine sulfate,  ≤ 1mcg/mL

Allergens

Mouse-serum protein, < 50 ng - no myelin basic protein can be detected at the detection threshold of the assay (< 2 ng/mL)

Gelatin, 500 mcg

Thimerosal, 0.007%

Media

Prepared by inoculating mice intracerebrally

Vero Cells

Packaging

Single dose vial + diluent

10-dose vial + diluent

Single dose pre-filled syringe with plunger stopper with or without a seperate needle

Routine Storage

2 to 8 C

Do not freeze

2 to 8 C

Do not freeze

updated May 2013

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety