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首页> 外文期刊>Vaccine >Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, IXIARO (R) (IC51), in 6 months of follow-up
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Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, IXIARO (R) (IC51), in 6 months of follow-up

机译：Vero细胞培养衍生的日本脑炎疫苗IXIARO（R）（IC51）在6个月的随访中的安全性分析

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Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO (R) 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 (R), for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO (R) vaccination, 435 subjects with a JE-VAX (R) (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 (R) (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO (R); 40% PBS + Alum vaccination). JE-VAX (R) 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 (R) (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX (R) (64%); as for subjects with serious AEs (1% IXIARO (R); 2% PBS + Alum vaccination, 1% JE-VAX (R)). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO (R) has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX (R)
机译：日本脑炎（JE）是亚洲最常见的病毒性脑炎。 IXIARO（R）是一种Vero细胞源灭活的JE病毒疫苗，最近在美国，欧洲，加拿大和澳大利亚得到了批准（商品名JESPECT）。IXIARO（R）的安全性和耐受性概述已有6年在7项III期试验中进行首次疫苗接种后的几个月，包括：3558名受试者至少进行了一次IXIARO（R）疫苗接种; 435名受试者进行了JE-VAX（R）（由BIKEN制造，由赛诺菲巴斯德公司分发）疫苗;以及657例含0.1％Al（OH）（3）（PBS +明矾）的磷酸盐缓冲盐溶液控制接种。报告用IXIARO（R）引起局部不良事件（AE）的受试者百分比（54％）与PBS +明矾疫苗接种（56％）相似，而系统性全身不良事件（40％IXIARO（R）; 40％PBS +明矾疫苗接种）。 JE-VAX（R）表现出较高的发生局部不良事件的频率（61％），但是出现频率较低的发生全身性不良事件的频率（36％）。使用IXIARO（R）（64％）进行任何主动和非主动AE的受试者的频率也类似于PBS +明矾疫苗接种（61％）和JE-VAX（R）（64％）;对于患有严重AE的受试者（1％IXIARO（R）; 2％PBS +明矾疫苗接种，1％JE-VAX（R））。在任何组中均未观察到严重的过敏反应。该安全性分析表明，IXIARO（R）具有良好的安全性，与PBS +明矾对照疫苗相当，并且似乎比JE-VAX（R）具有更好的局部耐受性

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