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A、C、Y、W135群脑膜炎球菌多糖疫苗安全性观察

Safety of tetravalent meningococcal A, C, Y,W135 vaccine

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【作者】 汤妍张吉凯梁剑蒋详顺苏家立谢学海夏艳辉邓寿平冯社庄黄易都陈义建黄竹航

【Author】 TANG Yan,ZHANG Ji-kai,LIANG Jian,JIANG Xiang-shun,SU Jia-li,XIE Xue-hai,XIA Yan-hui, DENG Shou-ping,FENG She-zhuang,HUANG Yi-du,CHEN Yi-jian,HUANG Zhu-hang (Guangdong Provincial Institute of Biological Products and Materia Medica ,Guangdong,Guangzhou 510440,China)

【机构】 广东省生物制品与药物研究所广东省疾病预防控制中心重庆智飞生物制品股份有限公司广宁县疾病预防控制中心博罗县疾病预防控制中心

【摘要】 目的观察A、C、Y、W135群脑膜炎球菌多糖疫苗在广东省广宁县和博罗县2~7岁人群中免疫后的安全性。方法研究者主动观察疫苗接种后30min,6、12、24、48、72h的局部和全身反应并记录在疫苗接种日记卡上,通过主动报告和定期随访的形式收集4天~4周期间的异常反应情况。结果共接种观察了2974名适龄儿童,发生疫苗接种不良事件378例,异常反应率12.71%,其中发热反应率10.96%,局部反应发生率1.85%;疫苗接种后30min至72h期间的全身和局部反应率分别为8.61%和1.82%。不良反应分级主要为2级以下,未观察到严重不良事件。所有全身反应症状和局部反应症状分别消失于接种后12d内和6d内。结论 A、C、Y、W135群脑膜炎球菌多糖疫苗在2~7岁人群中接种有较好的安全性。

【Abstract】 Objective To evaluate the safety of tetravalent meningococcal A ,C,Y,W135 vaccine in the population (aged 2-7 years old) from Boluo and Guangning county, Guangdong province. Methods Local and systemic reactions were recorded at 30 min, 6, 12, 24,48 and 72h after vaccination. Abnormal reactions were also recorded in the following 4 weeks. Results 2 974 children were vaccinated. 378 cases (12.71%) had adverse events. The incidence of fever and local reaction was 10.96% and 1.85% , respectively. The incidence of systemic and local reaction occurred at 30 min to 72h after immunization was 8.61% and 1.82% , respectively. Most of the side effects were classified as Grade 2 adverse reaction. Conclusion The tetravalent meningococcal A,C,Y,W135 vaccine was found to be safe for the children with an aged of 2-7 years old.

【基金】 广东省疫苗安全重点科研基地(2012A061300003)
  • 【文献出处】 热带医学杂志 ,Journal of Tropical Medicine , 编辑部邮箱 ,2013年07期
  • 【分类号】R186
  • 【被引频次】11
  • 【下载频次】167
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