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水痘减毒活疫苗流行病学保护效果及安全性研究 被引量:4

Post-marketing evaluation of the effectiveness and safety of a varicella attenuated live vaccine in ;China
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摘要 目的:评价A公司生产的水痘减毒活疫苗( varicella attenuated live vaccine, VarV)的流行病学效果及安全性。方法开展多中心试验,募集江苏、湖北、山东3省年龄在3~〈11岁之间的儿童共15002人作为观察对象。受试者按照随机、盲法、对照的原则分为实验组和对照组,分别接种水痘疫苗(观察苗)和腮腺炎疫苗(或麻腮疫苗)(对照苗),分析实验过程中观察到的临床水痘病例,以计算疫苗流行病学保护率。通过主动报告和定期随访的方式进行评估其安全性。结果观察期间,实验组的水痘发病率为0.147%,对照组的发病率为1.155%(P〈0.001),差异具有统计学意义。疫苗的保护率为87.27%。接种水痘疫苗后不良反应发生率低于其他文献报道。结论 A公司生产的VarV 具有良好的安全性和流行病学保护效果。 Objective To evaluate the effectiveness and safety of varicella attenuated live vaccine ( VarV) produced by A Co. Ltd. Methods We selected 3 provinces in China and enrolled 15 002 children aged 3-〈11 in this random, multicenter study. Participants were randomly divided into two groups: the ex-perimental group and the control group. Every varicella case was collected and recorded to calculate the vac-cine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Re-sults During the observation period, the incidence of varicella was 0. 147% in the experimental group and 1. 155% in the control group (P〈0. 001). The vaccine efficacy was 87. 27%. The adverse reaction rate af-ter vaccination was lower than the rates reported in other literatures. Conclusion The VarV produced by A Co. , Ltd. in China was effective and safe in preventing varicella.
作者 陈海平 刘小琴 沈红杰 马福宝 宋立志 张迟 沈心亮 过琴媛 徐斌 罗林云 Chen Haiping, Liu Xiaoqin, Shen Hongjie, Ma Fubao, Song Lizhi, Zhang Chi, Shen Xinliang, Guo Qinyuan, Xu Bin, Luo Linyun(China National Biotec Group Company Limited, Beijing 100029, China ; Changchun Keygen Biological Products Co. , Ltd. , Changchun 130062, China; Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China ; Shandong Center for Disease Control and Prevention, Jinan 250014, China ; ttubei Provincial Center for Disease Control and Prevention, Wuhan 430079, China )
出处 《中华微生物学和免疫学杂志》 CAS CSCD 北大核心 2016年第8期600-604,共5页 Chinese Journal of Microbiology and Immunology
关键词 水痘减毒活疫苗 多中心 疫苗效果 疫苗安全性 Varicella attenuated live vaccine Multicenter study Vaccine efficacy Vaccine safety
作者简介 通信作者:罗林云,Email:luolinyun@sinophaml.com,电话:010-84663393
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