A+C群脑膜炎球菌多糖结合疫苗上市后安全性研究  

Post-marketing Study on Safety of a Group A and C Meningococcal Polysaccharide Conjugate Vaccine

作　　者：傅传喜[1] 黄桂花[1] 崔敏[1] 贺晴[1] 许建雄[1] 王鸣[1] 

机构地区：[1]广州市疾病预防控制中心,广东广州510440

出　　处：《中国疫苗和免疫》2013年第6期529-532,共4页Chinese Journal of Vaccines and Immunization

基　　金：广东省广州市对外科学技术合作专项(编号:2012J5100005);广东省广州市医药卫生科学技术项目(编号:20121A011114);广东省科学技术计划项目(编号:2011B050300001);广东省省部产学研结合项目(编号:2012B091100045)

摘　　要：目的对A＋C群脑膜炎球菌多糖结合疫苗（Group A and C Meningococcal Polysaccharide Conjugate Vaccine，MPCV．AC）进行上市后安全性评价，为在人群中应用提供参考。方法2011年10月～2012年9月，在广州市采用分层随机抽样方法抽取5月龄～5岁受种儿童，连续随访3天，主动监测不良反应发生情况。采用整群随机抽样方法，对受种儿童进行被动监测，观察接种后MPCV．AC不良反应发生情况。结果主动监测262名受种儿童，5N23月龄婴幼儿（60人）未观察到不良反应，2～5岁儿童7人（3．4653％，7/202）出现轻度局部不良反应。10356名被动监测儿童接种MPCV-AC后，19例（0．1835％）报告轻度局部反应（主要为硬结和红、肿），9人（0．0869％）出现全身反应。结论儿童接种MPCV-AC有良好的安全性。Objective To evaluate the post-marketing safety profile of a group A and C meningoeoccal polysaccharide conjugate vaccine （MPCV-AC） and provide evidence for vaccination of MPCV-AC. Methods During October 2011 to September 2012, we selected children who were from 5 months to 5 years old by stratified random sampling method to conduct active surveillance activity through 3 day＇s follow-up continuously. And cluster sampling method was used in the passive surveillance activity. Adverse events following immunization were recorded. Results In the active surveillance activity, among 262 subjects, no adverse events were reported among those aged 5-23 months and local reactions were found in 7 （3.4653 % ） children aged 2-5 years. In the passive surveillance activity, 19 （0.1835 % ） children were reported local reactions （red, swell, and harden） and 9 （0.0869%0）with systemic reaction among 10356 children. Conclusions MPCV-AC is safe for children.

关 键 词：A+C群脑膜炎球菌多糖结合疫苗 安全性 

分 类 号：R186[医药卫生—流行病学] R515.2[医药卫生—公共卫生与预防医学]