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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。
Objective To observe the safety of live attenuated vaccine against freeze-dried chickenpox in children, and to provide basis for the development of varicella vaccination strategy. Methods The healthy children aged from 1 to 12 years old in Binhai New Area of Tianjin were selected as the observation objects according to the stratified stochastic principle and “inclusion and exclusion criteria ”, and were divided into groups of toddlers, preschool children and school-age children according to their physiological characteristics. The combination of active and passive monitoring was adopted to observe the adverse reactions within 42 days after inoculation of live attenuated vaccine of lyophilized chickenpox. Results A total of 7 546 people were observed and 62 patients were lost. The incidence of adverse reactions was 7.08%. The main adverse reactions were grade Ⅰ reactions (81.27%). The main adverse reactions were fever (89.51%), with no serious adverse reactions The incidences of adverse reactions in the three age groups of children, preschool children and school-age children were 7.90%, 6.88% and 6.36% respectively, with no significant difference (P> 0.05). The incidence of adverse reactions was 30 minutes after vaccination ~ 12 d, most concentrated in 1-3 days after vaccination, accounting for 89.51%. Conclusion The incidence of adverse reactions of live attenuated vaccinated freeze-dried varicella vaccine is not higher than other domestic research results, no serious adverse reactions, the vaccine has good safety.