Hib结合疫苗的安全性观察  

Haemophilus influenzae type b conjugate vaccine safety observation

作　　者：李秀红 潘红星[2] 王泽明 张艺飓[2] 

机构地区：[1]江苏省响水县疾病预防控制中心,盐城224600 [2]江苏省疾病预防控制中心,南京210009

出　　处：《江苏预防医学》2012年第6期30-32,共3页Jiangsu Journal of Preventive Medicine

摘　　要：目的了解b型流感嗜血杆菌结合疫苗(Hib)的安全性,为推广使用提供依据。方法采用随机、盲态、同类制品平行对照的Ⅲ期临床试验方法,分6～12月龄、1～5岁2个年龄组,各选取900名婴幼儿,以2∶1的比例,按免疫程序分别接种受试疫苗和对照疫苗,并对接种后AEFI发生情况进行比较。结果接种受试Hib结合疫苗后,AEFI发生率为18.44%;局部、全身反应率均较低,以弱反应为主;2种疫苗间AEFI发生率差异无统计学意义(P均>0.05)。结论 2种疫苗接种后均有良好的安全性。Objective To understand the safety of domestic Hib conjugate vaccine, and to provide the basis for promoting the use of it. Methods A total 1 800 infants were divided into 2 groups, one group with 900 infants ages ranged from 6 to 12 months, the other group with 900 infants ages ranged from 1 to 5 years. The ratio was 2：1 for receiving Hib vaccine immuniza- tion program and control vaccine with randomly,blinded and parallel phase III clinical trial method for similar products. After vaccination, the incidence of adverse reactions （AEFI） was compared between the two kinds of vaccines. Results After being vaccinated with hib conjugate vaccine,AEFI rate was 18.44%. The local and systemic reactions were relative lower, and weak reactions were dominated moreover, there was no significant difference between the two groups with AEFI incidence （P〈0. 05）. Conclusion The two kinds of Hib conjugate vaccine have good security after vaccination.

关 键 词：HIB结合疫苗 安全性 观察 

分 类 号：R186[医药卫生—流行病学]