کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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2403962 | 1102943 | 2010 | 7 صفحه PDF | دانلود رایگان |
Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO® is a Vero cell-derived, inactivated JE virus vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT).This overview of the safety and tolerability of IXIARO®, for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO® vaccination, 435 subjects with a JE-VAX® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH)3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO®; 40% PBS + Alum vaccination). JE-VAX® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX® (64%); as for subjects with serious AEs (1% IXIARO®; 2% PBS + Alum vaccination, 1% JE-VAX®). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX®.
Journal: Vaccine - Volume 28, Issue 39, 7 September 2010, Pages 6463–6469