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作 者:杨进[1] 叶强[2] 董柏青[1] 龚健[1] 崔萱林[3] 杨明[3] 廖和壮[1] 张杰[1] RionLeon Ochiai Ali Mohammad John Clemen
机构地区:[1]广西壮族自治区疾病预防控制中心细菌科,南宁530028 [2]中国药品生物制品检定所菌种室,北京100050 [3]兰州生物制品研究所菌苗一室,兰州730046 [4]国家疫苗研究所
出 处:《中国生物制品学杂志》2009年第7期699-701,共3页Chinese Journal of Biologicals
基 金:国际疫苗研究所资助项目(DOMIT-3)
摘 要:目的观察A+C群脑膜炎球菌多糖疫苗大规模接种后的速发接种反应。方法以A+C群脑膜炎球菌多糖疫苗为观察组,伤寒Vi多糖疫苗为对照组,按组群随机分层配对的原则,将观察现场分为108个组群,观察组和对照组各分配54个组群进行接种。建立接种反应监测系统,按统一表格和方法对两组的速发接种反应进行监测。结果两组共接种34 543人,其中A+C群脑膜炎球菌多糖疫苗接种18 167人,伤寒Vi多糖疫苗接种16 376人。A+C群脑膜炎球菌多糖疫苗速发接种反应率为0.44‰;伤寒Vi多糖疫苗速发接种反应率为0.79‰,二者差异无统计学意义;速发接种反应均出现在接种后15 min内,最早的出现在接种后5 min,速发接种反应中有2例为异常反应,但未出现严重反应。结论A+C群脑膜炎球菌多糖疫苗速发接种反应发生率低,预后良好。Objective To observe the immediate adverse reaction after mass vaccination of groups A +C meningococcal polysaceharide vaccine. Methods ,The populations in field were divided into 108 clusters consisting of 54 trial and 54 control clusters according to the principle of cluster randomization stratified and paired sampling, and vaccinated with groups A+C meningococcal polysaceharide vaccine and typhoid Vi polysaceharide vaccine respectively. An adverse event surveillance system was established to monitor the immediate reactions following vaccination campaign. Results A total of 34 543 persons were vaccinated, of whom 18 167 with groups A+C meningococcal polysaccharide vaccine and 16 376 with typhoid Vi polysaccharide vaccine. The immediate adverse reaction rates after vaccination with groups A+C meningoeoccal polysaccharide vaccine and typhoid Vi polysaccharide vaccine were 0. 44‰ and 0. 79‰ respectively, which showed no significant difference. All the immediate adverse reactions appeared within 15 min after vaccination, of which the earliest one within 5 min. Two cases of abnormal reactions were observed, but on severe reaction. Conclusion The immediate adverse reaction rate after vaccination of groups A+C meningococcal polysaccharide vaccine was low, indicating good safety of the vaccine.
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