冻干水痘减毒活疫苗现场流行病学效果研究(Ⅰ)

Study on Epidemiological Effect of the Freeze-dried Attinuated Live Varicella Vaccine

目的评价冻干水痘减毒活疫苗(Varicella Freeze-dried Attenuated Live Vaccine,VarV)的现场流行病学效果和疫苗安全性。方法选择近3年未发生过水痘流行、无水痘患病史、未接种过VarV的小学生和托幼机构儿童作为观察对象。采取随机、盲法、对照的方法,将入选的观察对象分成试验组2476人,接种VarV;对照组2534人,接种流行性腮腺炎减毒活疫苗。结果经追踪随访,水痘发病率试验组为0.8‰,对照组为8.7‰。根据二项分布概率法检验,差异有非常显著的统计学意义(B.P=0.000017)。疫苗效果(Vaccine Efficacy,VE)为90.8%,VE95%可信限下限为88.8%。结论VarV具有良好的现场流行病学保护效果和安全性。

Objective To evaluate the safety and epidemiological effect of the Freeze-dried Live attenuated varicella vaccine. Methods A random, double-blind control clinical trial was adopted. Results In the observation period, the incidence of varicella was 0.8‰ in the experimental group and 8.7‰ in control group. There was a significant difference （B.P=0.000017）. Vaccine effectiveness （VE（%）） was 90.8%, the lower limit of 95%CI was 88.7%. Conclusion The varicella vaccine produced by Changchun keygen biological products co., Ltd. was safe and effective.