b型流感嗜血杆菌结合疫苗大规模上市后安全性观察

Post-marketing safety of Haemophilus influenza type b conjugate vaccine

目的评价b型流感嗜血杆菌（Hib）结合疫苗大规模使用后的安全性。方法采用多中心、无对照设计，选择3-60月龄儿童接种Hib疫苗，收集每剂次接种后30d内的不良反应／事件，计算发生率。结果本研究共纳入有效观察对象13264名，共接种Hib疫苗26243剂次，报告不良反应／事件1475起，总发生率为5．62％。1级、2级、3级不良反应／事件发生率分别为4．36％、1．14％、0．11％，无4级不良反应／事件发生。局部反应和全身反应发生率分别为3．68％、1．94％。结论本研究受试者接种Hib疫苗后不良反应／事件发生率低，具有良好的安全性。

Objective To evaluate post-marketing safety of Haemophilus influenza type b （Hib） conju- gate vaccine. Methods A multicenter, non-controlled design was used to select 3-60 month old children to receive Hib vaccine and observe adverse reactions/events within 30 days of vaccination. Results We enrolled 13 264 subjects and administered 26 243 doses of Hib vaccine. Among children vaccinated, 1 475 adverse reactions/events were reported, for an overall incidence rate of 5.62% per dose adminis- tered. The incidence rates for grade 1, grade 2 and grade 3 adverse reactions/events were 4. 36%, 1.14% and 0. 11%, respectively, with no grade 4 adverse reactions/events observed. The incidences of local reactions and systemic reactions were 3.68% and 1.94%, respectively. Conclusions The inci- dence of adverse reactions/events after Hib vaccination was low; the vaccine was safe.