冻干水痘减毒活疫苗现场流行病学保护效果研究(Ⅲ)  

Study on Epidemiological Effect of the Varicella Attenuated Live Vaccine(Freeze-dried)(Ⅲ)

作　　者：张迟[1] 罗林云 叶建君[1] 陈海平 徐顺平[4] 余林生 蔡碧[1] 李书华[1] 赵明江[1] 付方 沈心亮 

机构地区：[1]湖北省疾病预防控制中心,武汉430079 [2]长春祈健生物制品有限公司,吉林长春130062 [3]北京天坛生物制品股份有限公司,北京100024 [4]麻城市疾病预防控制中心,湖北麻城436100 [5]英山县疾病预防控制中心,湖北英山436100 [6]中国生物技术集团公司,北京100029

出　　处：《中国疫苗和免疫》2012年第2期101-104,共4页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价冻干水痘減毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV-Fd)的安全性及流行病学效果。方法选择未患过水痘、流行性腮腺炎(腮腺炎),无接种禁忌证,且近一个月内未接种过其他预防性生物制品,年龄在3～9岁的托幼机构儿童和在校小学生4800人作为观察对象。按照随机、盲法、对照原则,将入选的观察对象分为试验组和对照组,各2400人,分别接种VarV-Fd和腮腺炎减毒活疫苗。结果经追踪随访,试验组水痘发病率为0.83‰,对照组为11.67‰,据二项分布概率法检验,差异有统计学意义(P<0.001)。VarV-Fd的保护率为92.89%,95%可信区间下限为82.68%。结论 VarV-Fd具有良好的安全性和现场流行病学保护作用。Objective To evaluate the safety, epidemiological effect of the varicella attenuated live vaccine （freeze-dried） （VarV-Fd）. Methods A random, double-blind control clinical trial was adopted. 4800 non-infected children aged 3-9 years old who had no contraindication and didn＇ t receive any vaccination within latest one month were selected and divided into experimental group （2400 children） and control group （2400 children）randomly. Results In the observation period, the incidence of varicella was 0.830 %o in the experimental group and 11.67 %. in control group. There was a significant difference （P〈0.001）. Vaccine effectiveness was 92.89%, the lower limit of 95%CI was 82.68%. Conclusion The VarV-Fd vaccine was safe and effective.

关 键 词：冻干水痘减毒活疫苗 随机对照临床试验 安全性 流行病学保护效果 

分 类 号：R186[医药卫生—流行病学] R511.5[医药卫生—公共卫生与预防医学]