适龄儿童接种人二倍体细胞甲型肝炎灭活疫苗不良事件观察  

Observation of adverse events following immunization with a human diploid cell based hepatitis A inactivated vaccine

作　　者：黄卓英[1] 孙晓冬[1] 任佳[1] 马晓英 郭翔[1] 李晓军[2] 杨佳平[2] 费怡[3] 陈红英[3] 陆红梅[4] 沈金花[4] Huang Zhuoying;Sun Xiaodong;Ren Jia;Ma Xiaoying;Guo Xiang;Li Xiaojun;Yang Jiaping;Fei Yi;Chen Hongying;Lu Hongmei;Shen Jinhua(Shanghai Municipal Center for Disease Control and Prevention,Shanghai 200336,China;Baoshan District Center for Disease Control and Prevention,Shanghai 201901,China;Pudong District Center for Disease Control and Prevention,Shanghai 200136,China;Songjiang District Center for Disease Control and Prevention,Shanghai 201620,China)

机构地区：[1]上海市疾病预防控制中心,上海200336 [2]上海市宝山区疾病预防控制中心,上海201901 [3]上海市浦东新区疾病预防控制中心,上海200136 [4]上海市松江区疾病预防控制中心,上海201620

出　　处：《中国疫苗和免疫》2021年第5期584-588,共5页Chinese Journal of Vaccines and Immunization

基　　金：上海市加强公共卫生体系建设三年行动计划(2020-2022年)公共卫生重点学科建设项目(GWV-10.1-XK16);上海市加强公共卫生体系建设三年行动计划(2020-2022年)超大城市公共卫生风险综合监测预警和应急响应能力建设项目(GWV-1.1)。

摘　　要：目的评价适龄儿童接种一种国产人二倍体细胞甲型肝炎灭活疫苗(Inactivated hepatitis A vaccine,HepA-I)的安全性。方法在上海市招募18-30月龄儿童,按0-6月免疫程序接种2剂次HepA-I,采用主动监测和被动监测分别观察接种后0-7d和≥8d发生的不良事件,分析报告发生率。结果受试者HepA-I接种后不良事件总发生率为51.24‰(293例);其中注射部位、全身不良事件发生率分别为31.48‰(180例)、19.76‰(113例);第1剂、第2剂接种后不良事件发生率分别为40.67‰(122例)、62.91‰(171例);1级、2级、3级、4级不良事件发生率分别为43.55‰(249例)、7.35‰(42例)、0.35‰(2例)、0.00‰。结论本研究HepA-I在适龄儿童接种具有良好的安全性。Objective To evaluate the safety of a domestic human diploid cell based hepatitis A inactivated vaccine(HepA-I)among age-eligible children.Methods We recruited 18-30-month-old children in Shanghai and administered two doses of HepA-I using a 0-6-month immunization schedule.We used active and passive monitoring to observe adverse events within 0-7 and≥8 days after vaccination and determined the incidence of reported adverse events.Results The overall per dose incidence of adverse events after HepA-I administration was 51.24‰(293 cases).Per dose incidences for injection site and systemic adverse events were 31.48‰(180 cases)and 19.76‰(113 cases).Incidences for the first dose and the second dose were 40.67‰(122 cases)and 62.91‰(171 cases).Incidences for grade 1,2,3,and 4 adverse events were 43.55‰(249 cases),7.35‰(42 cases),0.35‰(2 cases),and 0.00‰.Conclusions The HepA-I used in the study has a good safety profile among age-eligible children.

关 键 词：甲型肝炎疫苗 预防接种 不良事件 主动监测 

分 类 号：R186[医药卫生—流行病学]