冻干水痘减毒活疫苗(无明胶)常规条件下的安全性观察

Safety observation on lyophilized live attenuated varicella vaccine( without gelatin)under normal conditions

目的评价由长春百克生物科技股份公司生产的冻干型水痘减毒活疫苗（无明胶）初次免疫和加强免疫的安全性。方法选取武鸣县1—15岁儿童进行初次免疫和／或加强免疫，按Ⅳ期临床试验设计进行，不编盲，不设对照组。观察接种疫苗后3d内的不良反应发生情况并记录在监测卡上。结果不良反应发生率无性别和年龄上的差异，但在不同接种针次上存在显著性差异，加强免疫的不良反应发生率高于初次免疫，但两者的发生率均较低，总不良反应发生率为137．98／10万。主要表现为发热和接种部位发红，所有报告病例均不严重，全部病例均在短时间内恢复，无严重接种不良反应发生。结论冻干水痘减毒活疫苗（无明胶）的初次免疫和加强免疫的安全性较好，值得应用无明胶冻干水痘减毒活疫苗推广2剂次的接种程序。

Objective To evaluate the safety of primary immune and secondary immune of lyophilized live atten- uated varicella vaccine （no gelatin） produced by Changchun baike Biological Technology Co. Ltd. Methods According to the phase IV clinical trial was designed, and a primary immune and/or secondary immune study was carried out in children aged 1 - 15 years old in Wuming. Within 3 days after vaccination, the incidence of adverse reactions was observed and recorded in the monitoring card. Results The incidence of adverse reac- tions had no gender and age differences, but there was significant difference on inoculating needle times. The adverse event incidences of secondary immune was higher than that of primary immune, while both were low- er, and the total incidence reaction rate was 137.98/100 000. The main incidences were fever and redness in inoculation site, all reported cases were not serious and recovered in a short period of time, and no serious ad- verse reaction of vaccination occurred. Conclusions The primary immune and secondary immune of lyophilized live attenuated varicella vaccine possess good safety, thus it is worth promoting the 2 dose vaccination program with it.