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.
出处
《中国疫苗和免疫》
CAS
2012年第2期101-104,共4页
Chinese Journal of Vaccines and Immunization
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
Varicella attenuated live vaccine （freeze-dried）
Random-control clinical trial
Safety
Epidemiological effect
