AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗安全性观察

Safety of Post-marketing Group A and C Meningococcal Conjugate and Haemophilus Type b Conjugate Combined Vaccine

目的评价AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗对2~71月龄儿童使用后的安全性。方法 360名2~5月龄儿童接种AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗后,通过主动监测和跟踪观察,收集接种对象所出现的速发反应、全身反应和局部反应及其他不良反应情况并进行统计分析。结果未出现速发接种反应,所监测的360名儿童中,接种1 032人次,共发生不良反应345人次,发生率33.43%,全身不良反应的发生率为24.03%,最终研究者判断与预防接种可能有关的全身不良反应的发生率为8.12%,未观察到其他与疫苗接种相关的不良反应。结论此次对AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗使用安全性现场观察。总体接种无严重不良反应外,其余反应轻微,发热为主要为不良反应,绝大部分反应能在7天内自行消失,未观察到出现紫癜等全身不良反应,AC群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗使用后有良好的安全性。

Objective To evaluate the meningococcal AC（combination） of Haemophilus influenzae type B（binding）combined vaccine for 2 to 71 months after the use of the safety of children. Methods 360 2-5 month old children with meningococcal AC（combination） of Haemophilus influenzae type B vaccine（combination）, through active monitoring and tracking observation, collecting the immediate vaccination reaction, systemic and local reaction and other adverse reactions and statistical analysis. Results did not show immediate adverse reaction, 360 children monitoring,inoculation of 1 032 passengers, a total of 345 adverse reactions occurred, the incidence rate was 33.43 %, the incidence of adverse reactions was 24.03 %, eventually the researchers estimate and vaccination may be systemic adverse reactions related to the occurrence rate was 8.12 %, which was not observed for other associated with vaccination adverse reactions. Conclusion the meningococcal AC（combination） of Haemophilus influenzae type B（binding） combined vaccine safety observation. No serious adverse reaction in overall vaccination, the reactions were mild, fever was the main adverse reaction, most of the reaction can disappear by itself in 7 days, not observed that the presence of systemic adverse reactions such as purpura, meningococcal AC（combination） of Haemophilus influenzae type B（binding） combined vaccine has good safety after use.