Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®).
Vaccine
; 29(47): 8669-76, 2011 Nov 03.
Article
em En
| MEDLINE
| ID: mdl-21907747
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
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Vacinas contra Encefalite Japonesa
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Vírus da Encefalite Japonesa (Espécie)
Tipo de estudo:
Observational_studies
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Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
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Aged80
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Animals
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2011
Tipo de documento:
Article