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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 evaluate the safety of the Haemophilus influenzae type b (Hib) conjugate vaccine after being marketed. Methods Children aged 2-59 months were vaccinated with Hib conjugate vaccine. Adverse reactions / events from 0-30 days after the first dose of vaccine were collected to analyze the incidence of adverse reactions / events. Results Of the 13,000 subjects, 11 730 eligible patients were enrolled, of which 1 090 subjects had adverse reactions / events. A total of 1 274 adverse reactions / events were reported, with a total adverse reaction / event rate Was 9.29%. Adverse reactions / events were mild and transient. The incidence of grade 3 and above adverse events / events was 0.09%. Conclusion The Hib conjugate vaccine in this study is safe.