| 董柏青,叶强,崔萱林,杨进,龚健,杨明,廖和壮,韦士良,张杰,吴兴华,司国爱,杨宏徽,Ataru Tsuzuki,JinKyung Park,Mohammad Ali,R. Leon Ochiai,John D. Clemens.A+C群脑膜炎球菌多糖疫苗安全性评估[J].Chinese journal of Epidemiology,2007,28(5):417-421 |
| A+C群脑膜炎球菌多糖疫苗安全性评估 |
| Evaluation on the safety of a group A + C meningococcal polysaccharide vaccine |
| Received:December 15, 2006 |
| DOI： |
| KeyWord: 疫苗,A+C群脑膜炎球菌多糖 疫苗,伤寒Vi多糖 整群随机临床观察 接种反应 安全评估 |
| English Key Word: Group A+c meningococcal polysaccharide vaccine Typhoid Vi polysaccharide vaccine Cluster randomized trial Side effect Safety evaluation |
| FundProject:DOMI伤寒Vi疫苗国际示范项目资助(DOMI T-3) |
| Author Name | Affiliation | E-mail | | DONG Bai-qing | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | YE Qiang | 中国药品生物制品检定所 | | | CUI Xuan-lin | 兰州生物制品研究所 | | | YANG Jin | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | yyyjin@126.com | | GONG Jian | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | YANG Ming | 兰州生物制品研究所 | | | LIAO He-zhuang | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | WEI Shi-liang | 广西河池市金城江区卫生局 | | | ZHANG Jie | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | WU Xing-hua | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | SI Guo-ai | 广西河池市金城江区疾病预防控制中心 | | | YANG Hong-hui | Guangxi Center for Disease Prevention and Control, Nanning 530021, China | | | Ataru Tsuzuki | International Vaccine Institut | | | JinKyung Park | International Vaccine Institut | | | Mohammad Ali | International Vaccine Institut | | | R. Leon Ochiai | International Vaccine Institut | | | John D. Clemens | International Vaccine Institut | |
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| Abstract: |
| 目的 评估A+C群脑膜炎球菌多糖疫苗的安全性。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，按整群随机分层配对的原则，将研究现场分为108个组群，观察组和对照组各分配54个组。对两组同时建立接种反应监测系统，按统一表格和方法对两组的接种反应进行监测、记录，并进行流行病学调查。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‰，一般接种反应率为0。38‰;伤寒Vi疫苗速发接种反应率为0。79‰，一般接种反应率为0。73‰;跟踪随访接种反应对象共1239人，其中接种A+C群脑膜炎球菌多糖疫苗的771人，接种伤寒Vi疫苗的468人。接种后第1天，A+C群脑膜炎球菌多糖疫苗组的局部反应发生率要明显高于伤寒Vi疫苗(χ2=13。98，P=0。0002);接种后第2-3天局部反应和全身反应的发生率，两组差异无统计学意义;两组各自接种人群和未接种人群发热发生率的差异无统计学意义，两组已接种人群的发热发生率差异也无统计学意义;两组均未发现严重反应。结论 A+C群脑膜炎球菌多糖疫苗与伤寒Vi疫苗均可在不同年龄组人群开展大规模接种，局部及全身接种反应轻微，接种反应率低，有良好的安全性。 |
| English Abstract: |
| Objective To evaluate the safety of a group A+c meningococcal polysaccharide vaccine as part of a phaseⅣclinical trial．Methods The study area was divided into 1o8 clusters according to the principle of cluster randomization，stratified and paired sampling Methods．54 out of 108 clusters served as observation groups were administered A+C vaccine， while the rest 54 groups were administered Vi polysaccharide vaccine． An adverse event surveillance system was established to monitor the adverse events fo1lowing the vaccination campaign．Identical fom and Methods were used for data collection to investigate the adverSe events fo1lowing the vaccination of both A+C vaccine and Vi vaccine．Results 34 543 people were vaccinated，including 18 167 of whom received A+C vaccine，while the other 16376 received Vi vaccine． The rates of immediate injection reaction and unsolicited non—serious adverse events from A+C vaccine group were 0．44‰and 0．38‰while of Ⅵ vaccine group were 0．79‰and 0．73‰respectively．At the solicited adverse event survey on 3一day—post—vaccination，1239 vaccinees were foUowed-up including 771 received A+C vaccine and 468 received Vi vaccine．The local injection reaction rate of A+C vaccine group on the 1“day was significantly higher(X2=13．98，P=o．ooo2)than that of Vi vaccine group．Neither the local injection reaction rate nor the system reaction rate between both groups was significantly different on 2nd and 3rd day，post vaccination． It was not statistically different when comparing fever onset rate between those who received vaccine and those who did not， in each vaccine group．There were no serious adverse events observed．Conclusion Results showed that the side effects of A+C vaccine and the Vi vaccine were mild and safe for vaccination campaigns targeting on populations at different age． |
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