摘要
目的评价b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗上市后的安全性。方法选择2-59月龄儿童接种Hib结合疫苗,收集首剂疫苗免疫后0-30天的不良反应/事件,分析不良反应/事件发生率。结果在13 000名受试者中,征集到合格受试者11 730名,其中1 090名受试者发生不良反应/事件,共发生不良反应/事件1 274项,总不良反应/事件发生率为9.29%,不良反应/事件多为轻微和一过性的,3级及以上不良反应/事件发生率为0.09%。结论本试验的Hib结合疫苗安全性良好。
Objective To assess the safety of haemophilus influenzae type b（Hib） conjugate vaccine in a post-marketing study.Methods 13 000 infants aged 2-59 months were invited to be vaccinated with Hib conjugate vaccine.All adverse reactions/events within 30 days of the first-dose were collected to determine incidence rates.Results Among 13 000 recruited subjects,11 730 were qualified for the study.A total of 1 274 adverse reaction/events occurred in 1 090 subjects.The overall incidence of adverse reactions/events was 9.29%;most were mild and transient.The incidence of grade 3 or higher adverse reactions/events was 0.09%.Conclusions The Hib conjugate vaccine in the study had good post-marketing safety.
出处
《中国疫苗和免疫》
北大核心
2017年第1期26-28,33,共4页
Chinese Journal of Vaccines and Immunization
关键词
B型流感嗜血杆菌结合疫苗
上市后安全性
Haemophilus influenzae type b conjugate vaccine
Post-marketing
Safety
