大规模冻干A+C群脑膜炎球菌多糖结合疫苗接种后安全性观察  

The safety of freeze-dried group A/C meningococcal polysaccharide conjugate vaccine after the mass immunization in infant and children in Liuzhou City, China

作　　者：崔雪莲[1] 吴昕[1] 黎明强[1] 李艳萍[2] 马波 袁琳 

机构地区：[1]柳州市疾病预防控制中心,广西柳州545007 [2]广西壮族自治区疾病预防控制中心,广西南宁530028 [3]玉溪沃森生物技术有限公司,云南玉溪653100

出　　处：《现代预防医学》2015年第1期143-146,共4页Modern Preventive Medicine

基　　金：广西壮族自治区卫生厅计划课题(Z2013636)

摘　　要：目的了解冻干A＋C群脑膜炎球菌多糖结合疫苗（MCV—A／C）在大规模人群中使用的安全性。方法对入选的9111名3～71月龄的婴幼儿接种MCV—MC，3～5月龄儿童免疫3针，每针间隔1个月；6～23月龄儿童免疫2针，每针间隔1个月；24—71月龄儿童免疫1针。对他们进行全身及局部不良反应观察和记录。结果总的局部不良反应率为1．63％，各种局部不良症状发生率分别为发红0．86％、肿胀0．54％、硬结0．48％、疼痛0．33％、瘙痒0．54％，均低于1％；总的全身不良反应率为14．98％，除发热发生率为12．75％外，其余全身不良症状发生率分别为皮疹0．78％、乏力0．42％、烦躁1．79％、呕吐0．92％、腹泻1．69％，都低于2％，全身和局部不良反应以轻度为主，且多在反应发生后3d内恢复，无疫苗引起的严重不良事件，无致残及死亡事件发生。结论冻干A＋C群脑膜炎球菌多糖结合疫苗在3～71月龄的婴幼儿中大规模接种是安全的。Objective To learn the safety of freeze-dried group A/C meningococcal polysaccharide conjugate vaccine （MCV-A/C） in Chinese healthy infant and children in Liuzhou City, Guangxi Province. Methods 9111 children 3 - 71 months old were divided into 3 groups according to the age （3 - 5, 6 - 23 and 24 - 71 months）. Children 3-5 months old were injected with 3 doses every month, while those at ages of 6-23 months were injected with 2 doses every month, and those 24-71 months old were injected with 1 dose. Then we observed and recorded the systemic and local adverse reactions after each dose. MCV-A/C was manufactured by Walvax Biotechnology Co., LTD. Safety was evaluated descriptively. Results The local adverse reactions rate was 1.63%, and the incidence of local adverse symptoms were less than 1%. In addition to 12.75% fever rate, the systemic adverse reaction rate was 14.98%, and the incidences for other systemic adverse symptoms were lower than 2%. Generally, the systemic and local adverse reactions were mild, and the reaction occurred within 3 days after recovery. No serious adverse event or disability or death caused by the vaccine. Conclusion MCV-A/C in the children 3 - 71 months old shows good safety, and mass immunization is safe.

关 键 词：冻干A+C群脑膜炎球菌多糖结合疫苗 安全性 大规模接种 

分 类 号：R181.8[医药卫生—流行病学]