国产水痘减毒活疫苗上市后安全性观察

Post-marketing safety monitoring of a domestic Live Attemuatal Varicella Vaccine

目的评价一种国产水痘减毒活疫苗的上市后安全性。方法在河南省新野县、湖南省隆回县和湖北省松滋市,对1~12岁无水痘病史、无水痘疫苗接种史的观察对象组织自愿、常规接种,接种后分别于30 min、24 h、48 h、72 h、7 d、14 d、28 d收集统计不良反应情况。结果共接种观察对象9135例,征集到不良反应12例,总不良反应发生率为0.13%。全身反应以轻、中度发热为主。不良反应发生时间主要分布在48 h内,72 h后均可自愈。不同年龄段和不同疫苗批次间无显著性差异。结论该国产水痘减毒活疫苗在目标人群中应用具有良好的安全性,可推广使用。

Objective To evaluate the post-marketing safety of a domestic varicella vaccine while promoting vaccination.Methods In Xinye county(Henan Province),Longhui county(Hunan Province),and Songzi city(Hubei Province),the voluntary vaccination was routinely performed in healthy 1-12 year-old children with no history of varicella disease or varicella vaccination.The adverse reactions were documented and analyzed at 30 min,24 h,48 h,72 h,7 d,14 d,and 28 d after inoculation.Results Twelve adverse cases were reported in a total of 9135 subjects surveyed,with the adverse reaction rate of 0.13%.Systemic reactions were mainly mild or moderate fever.The adverse reactions appeared primarily within 48 h after vaccination,and were self-healed 72 h later.The adverse reaction rates among various age groups and batches of vaccines used showed no significant difference.Conclusion This domestic varicella vaccine shows good safety and is worth promoting usage in target market.