国产维赛瑞安甲型肝炎灭活疫苗在常规接种条件下的安全性观察

Observation on safety of homebred inactivated hepatitis A vaccine( human diploid cell) under conventional inoculation conditions

目的评价由中国医学科学院医学生物学研究所研制的甲型肝炎灭活疫苗（人二倍体细胞）上市后的安全性。方法在常规接种条件下，选取武呜县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3天内的不良反应发生情况并记录在监测卡上。结果共观察10310人次，总不良反应发生率为83．41／万（86／10310）。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，初次免疫者不良反应发生率为99．54／万（78／7836），加强免疫的不良反应发生率为32．34／万（8／2474），前者高于后者，但两者的发生率均较低。不良反应分为全身反应和局部反应，全身反应均表现为发热，发生率为66．93／万；局部反应发生率为16．49／万，主要表现为接种部位发红、痒痛。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。结论国产甲型肝炎灭活疫苗（维赛瑞安）上市后是安全的，在常规接种条件下其初次免疫和再次免疫发生的不良反应程度轻微、发生率低，安全性好，值得进一步推广应用。

[ Objective ] To evaluate the safety of inactivated hepatitis A vaccine { human diploid cell} made by the Institute of Medi- cal Biology of China Medical Academy of Sciences. [ Methods] According to the design of phase IV clinical trial, a primary immune and/or secondary immune study was carried out in children aged 1-15 years in Wumiug County under the conventional inoculation conditions. The blind method was not adopted, and there was no control group. The incidence of adverse reactions within 3 days af- ter vaccination was observed, and recorded in the monitoring card. [ Results ] A total of 10 310 children were observed, and the total incidence rate of adverse reactions was 83.41/10 000 [86/10 310}. There were no significant differences in the incidence rates of adverse reactions among different sex and age groups, but the difference between primary immune and secondary immune was signif- icant. The incidence rates of adverse reactions of primary immune and secondary immune was 99.54/10 000 （78/7 836 ） and 32. 34/10 000 （ 8/2 474 } , which the former was higher than the latter, while both two were lower relatively. Adverse reactions in- eluded systemic reactions and local reactions. The systemic reactions appeared as fever, and the incidence rate was 66.93/10 000. The incidence rate of local reactions was 16.49/10 000, which mainly appeared as the nabefaction, itch and pain at vaccination site. All reported cases were not serious, and recovered in a short period of time. There were no serious adverse reactions of vacci- nation. [ Conclusion] The homebred inactivated hepatitis A vaccine [human diploid cell ） shows good safety after marketing. Under the conventional inoculation conditions, the adverse reactions of primary immune and secondary immune are mild, with low inci- dence rate and good safety, which the vaccine is worthy of further popularization and application.