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目的评价AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗(Men AC-Hib)上市后在2~71月龄儿童接种的安全性。方法在云南省7个县(市、区)选择2~71月龄健康者接种Men AC-Hib,采用被动监测方式观察和收集接种后不良事件个案信息,对各种不良反应发生率进行分析。结果收集到40 226名观察对象的不良事件合格监测表格43 206份。观察对象接种Men AC-Hib后,局部反应主要为接种部位的皮疹(3例,发生率0.008%)、发红(3例,发生率0.008%)、肿胀(3例,发生率0.008%)和硬结(1例,发生率0.003%);全身反应主要为发热(19例,发生率0.053%)、变态反应(10例,发生率0.027%)。在20例发热病例中,65%发生在接种当天,20%发生在接种后1天,15%发生在接种后2~7天。结论 2~71月龄儿童接种Men AC-Hib具有良好的安全性。
Objective To evaluate the safety of vaccination of children aged 2 to 71 months after the introduction of Men AC-Hib meningococcal (combined) Meningococcal (combined) vaccine (AC) group AC. Methods Men AC-Hib was selected in healthy volunteers aged 2 ~ 71 months in 7 counties (cities and districts) in Yunnan Province. The passive surveillance methods were used to observe and collect information on cases of adverse events after inoculation, and the incidence of various adverse reactions was analyzed. Results A total of 206 206 cases of conformity monitoring of adverse events were collected from 40 226 observers. After inoculation of Men AC-Hib, the local reactions were mainly rash at the site of vaccination (3 cases, 0.008% incidence), redness (3 cases, incidence 0.008%), swelling (3 cases, incidence 0.008%) and Induration (1 case, the incidence of 0.003%); systemic reactions were mainly fever (19 cases, the incidence of 0.053%), allergic reactions (10 cases, the incidence rate of 0.027%). Of the 20 cases of fever, 65% occurred on the day of inoculation, 20% occurred 1 day after inoculation, and 15% occurred 2 to 7 days after inoculation. Conclusions Men AC-Hib vaccinated in children aged 2 to 71 months has good safety.