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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 and epidemiological effects of Varicella Attenuated Live Vaccine (Freeze-dried; VarV-Fd). Methods Children who did not have chickenpox, mumps, no vaccination contraindications and who had not been vaccinated with other prophylactic biological products in the recent one month, kindergarten children aged 3 to 9 and schoolchildren 4800 people as the observation object. According to the randomized, blinded and control principles, the selected subjects were divided into trial group and control group, with 2,400 persons in each group. Vaccinated with VarV-Fd and mumps attenuated live vaccine respectively. Results After follow-up, the incidence of chickenpox in the experimental group was 0.83 ‰, while that in the control group was 11.67 ‰. According to the binomial distribution probability test, the difference was statistically significant (P <0.001). The protection rate of VarV-Fd was 92.89%, and the lower limit of 95% confidence interval was 82.68%. Conclusion VarV-Fd has good safety and on-site epidemiological protection.