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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 initial immunization and boost of live attenuated freeze-dried varicella vaccine (gelatin-free) produced by Changchun Bioscience and Biotechnology Corporation. Methods The children aged from 1 to 15 years old in Wuming County were selected for primary immunization and / or booster immunization. According to the phase IV clinical trial design, they were not blind and no control group was established. The incidence of adverse reactions within 3 days after vaccination was observed and recorded on the surveillance card. Results The incidence of adverse reactions had no difference in sex and age, but there were significant differences in the number of needle injections. The incidence of adverse reactions to booster immunization was higher than that of primary immunizations, but the incidence of adverse reactions was low and the total adverse reactions The incidence was 137.98 / 100000. The main manifestations of fever and vaccination site redness, all reported cases are not serious, all cases were recovered in a short period of time, no serious adverse reactions to vaccination. Conclusions The primary immunization and booster immunization of the live attenuated freeze-dried varicella vaccine (gelatin-free) is safe. It is worth using the vaccination program to promote 2 doses of live attenuated vaccine without gelatin.