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 17 years 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 2010
This page was last updated on January 08, 2013 © 2010 Institute for Vaccine Safety