title: Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®).
abstract: Japanese encephalitis (JE) is the most common cause for viral encephalitis in Asia and can be effectively prevented by vaccination. IXIARO(®) is a Vero cell-derived, inactivated JE virus vaccine which has been licensed and distributed in the US, Europe, Canada, Hongkong, Israel, and distributed in Australia under the trade name JESPECT(®). This paper reviews the safety profile of IXIARO(®) in the first 12months after licensure and discusses the observed profile in the context of clinical trial results for IXIARO(®) and post-marketing safety data for JE-VAX(®). The clinical safety profile is derived from a pooled analysis including safety data from 10 phase III trials in 4043 subjects who received at least one IXIARO(®) vaccination and were followed-up for up to 3years after the primary immunization. Local and systemic tolerability of IXIARO(®) was similar to an earlier safety analysis at the time of licensure of the vaccine. In post-marketing AE reports, the system organ classes affected following vaccination with IXIARO(®) were similar to the previously observed clinical trial profile. No serious allergic reactions were observed in the 12-month post-marketing period. This comprehensive safety review confirms the good safety profile of IXIARO(®) in clinical and post-marketing use.
authors: Intercell AG, Campus Vienna Biocenter 3, A-1030 Vienna, Austria. eschuller@intercell.com
authors: Elisabeth
authors: E
authors: Schuller
authors: Anton
authors: A
authors: Klingler
authors: Katrin
authors: K
authors: Dubischar-Kastner
authors: Shailesh
authors: S
authors: Dewasthaly
authors: Zsuzsanna
authors: Z
authors: Müller
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D002522:Chlorocebus aethiops; D017326:Clinical Trials, Phase III as Topic; D004664:Encephalitis Virus, Japanese / Q000254:growth & development / Q000276:immunology* / Q000302:isolation & purification; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000009:adverse effects* / Q000276:immunology / Q000302:isolation & purification; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D014709:Vero Cells; D055815:Young Adult
chemical_list: D022321:Japanese Encephalitis Vaccines