冻干水痘减毒活疫苗的安全性评价

目的观察儿童接种冻干水痘减毒活疫苗的安全性,为制定水痘疫苗接种策略提供依据。方法按照分层随机原则及"入选和排除标准"选择天津市滨海新区年龄在1～12岁的健康儿童作为观察对象,并按照生理特点分为幼儿、学龄前儿童和学龄儿童组。采取主动和被动监测结合的方式,观察接种冻干型水痘减毒活疫苗后42 d内不良反应发生情况。结果共有效观察7 546人,失访62人,不良反应发生率为7.08%;不良反应以Ⅰ级反应为主,占81.27%;不良反应中以发热为主,占89.51%,未出现严重不良反应;幼儿、学龄前儿童和学龄儿童3个年龄组不良反应发生率分别为7.90%、6.88%和6.36%,差异无统计学意义(P>0.05);不良反应发病时间为接种疫苗后30 min～12 d,多数集中在接种疫苗后1～3 d,占89.51%。结论接种冻干水痘减毒活疫苗的不良反应发生率不高于国内其他研究结果,未出现严重不良反应,疫苗具有很好的安全性。

Safety of freeze-dried live attenuated varicella vaccine

Objective To observe safety of freeze-dried live attenuated varicella vaccine in children.Methods Healthy children aged 1 to 12 years in Binhai New Zone of Tianjin City were selected as subjects according to the stratified randomization principle and criterion for inclusion and exclusion,and divided into infant,preschooler and school age children groups,of whom the adverse reactions within 42 d after inoculation with freeze-dried live attenuated varicella vaccine were observed by active and passive surveillance.Results The trial was completed in 7 546 subjects while failed to complete in 62 subjects.The adverse reaction rate was 7.08%.Of the adverse reactions,81.27% were of gradeⅠ,89.51% were fever,and no severe reactions were observed.The adverse reaction rates in infants,preschoolers and school age children were 7.90%,6.88% and 6.36% respectively,which showed no significant difference(P > 0.05).The adverse reactions appeared 30 min to 12 d,mainly 1 ~ 3 d,after inoculation.Conclusion The adverse reaction rate of freeze-dried live attenuated varicella vaccine was not more than those reported by other researchers in China,and no severe reactions were observed,indicating high safety of the vaccine.