汤妍,杜飞,陈海平,周启富,苏家立,柴文清,夏艳辉,温万敏,陈晓荣,刘志强,黄清霄,刘小琴,黄竹航,梁剑

• 1:广东省生物制品与药物研究所
• 2:四川省疾病预防控制中心
• 3:中国生物技术股份有限公司
• 4:雅安市疾病预防控制中心

摘要(Abstract)：

目的以比利时葛兰素史克(GlaxoSmithKline,GSK)生物制品公司生产的威可檬(Varilrix)冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)作为对照,评价上海(Shanghai,SH)生物制品研究所有限责任公司生产的VarV-Fd的免疫原性和安全性。方法采用随机、双盲、对照方法,对广东省和四川省的467名1~3岁儿童进行了临床观察,比较接种两种VarV-Fd后的抗体(模抗原免疫荧光抗体法,Fluorescent Antibody to Membrane Antigen,FAMA)阳转率和免疫成功率,抗体几何平均滴度(Geometric Mean Titer,GMT)和不良反应发生率。结果接种SH VarV-Fd和GSK VarV-Fd后,抗体阳转率和免疫成功率分别为81.04%和81.59%,GMT分别为1∶8.829和1∶9.671,不良反应发生率分别为10.17%和7.36%。抗体阳转率和免疫成功率(χ2=0.020,P=0.886)、GMT(t=0.786,P=0.432)、不良反应发生率(χ2=1.151,P=0.283)的差异均无统计学意义。结论 SH VarV-Fd与GSK VarV-Fd均具有良好的免疫原性和安全性。

关键词(KeyWords)： 冻干水痘减毒活疫苗;免疫原性;安全性

Abstract:

Keywords:

基金项目(Foundation): 广东省疫苗安全重点科学研究基地(编号:2012A061300003)

作者(Author): 汤妍,杜飞,陈海平,周启富,苏家立,柴文清,夏艳辉,温万敏,陈晓荣,刘志强,黄清霄,刘小琴,黄竹航,梁剑

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