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Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®).
Vaccine 2011; 29(47):8669-76V

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+Show Affiliations

Intercell AG, Campus Vienna Biocenter 3, A-1030 Vienna, Austria. eschuller@intercell.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article

Language

eng

PubMed ID

21907747

Citation

Schuller, Elisabeth, et al. "Safety Profile of the Vero Cell-derived Japanese Encephalitis Virus (JEV) Vaccine IXIARO(®)." Vaccine, vol. 29, no. 47, 2011, pp. 8669-76.
Schuller E, Klingler A, Dubischar-Kastner K, et al. Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®). Vaccine. 2011;29(47):8669-76.
Schuller, E., Klingler, A., Dubischar-Kastner, K., Dewasthaly, S., & Müller, Z. (2011). Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®). Vaccine, 29(47), pp. 8669-76. doi:10.1016/j.vaccine.2011.08.117.
Schuller E, et al. Safety Profile of the Vero Cell-derived Japanese Encephalitis Virus (JEV) Vaccine IXIARO(®). Vaccine. 2011 Nov 3;29(47):8669-76. PubMed PMID: 21907747.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO(®). AU - Schuller,Elisabeth, AU - Klingler,Anton, AU - Dubischar-Kastner,Katrin, AU - Dewasthaly,Shailesh, AU - Müller,Zsuzsanna, Y1 - 2011/09/10/ PY - 2011/05/17/received PY - 2011/08/22/revised PY - 2011/08/28/accepted PY - 2011/9/13/entrez PY - 2011/9/13/pubmed PY - 2012/2/9/medline SP - 8669 EP - 76 JF - Vaccine JO - Vaccine VL - 29 IS - 47 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/21907747/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01394-6 DB - PRIME DP - Unbound Medicine ER -