安徽省部分地区1-12岁健康儿童水痘减毒活疫苗接种不良反应观察

Adverse reactions following vaccination with varicella attenuated live vaccine among healthy children aged 1-12 years:an observational study in areas of Anhui province

目的评价适龄儿童一款水痘减毒活疫苗(Varicella attenuated live vaccine,VarV)接种不良反应发生率。方法在安徽省5个地市预防接种门诊招募1-12岁健康儿童,观察接种1剂次VarV后0-30 d不良反应,分析不良反应发生率。结果本研究共纳入9169例受试者,接种VarV后不良反应总发生率为1.09%(100例),其中局部反应、全身反应发生率分别为0.69%(63例)、0.46%(42例),各以接种部位疼痛(0.40%)和发热(0.26%)发生率最高,未发生3级/4级或严重不良反应和特殊关注不良事件。1-3岁、4-12岁受试者不良反应发生率分别为1.47%(64/4347)、0.75%(36/4822)(χ^(2)=11.16,P<0.001)。结论1-12岁健康儿童接种1剂次VarV后不良反应轻微,发生率在预期范围内。

Objective To evaluate incidences of adverse reactions following vaccination with varicella attenuated live vaccine(VarV) among age-eligible children.Methods We recruited healthy children aged 1-12 years from vaccination clinics in five prefectures of Anhui province and followed them for adverse reactions 0-30 days after one-dose of VarV to determine incidences.Results A total of 9 169 subjects were included in the study. The overall incidence of adverse reactions after VarV vaccination was 1.09%(100 cases), with 0.69%(63 cases) local reactions and 0.46%(42 cases) systemic reactions;respective highest incidences were 0.40% for injection-site pain and 0.26% for fever. No level 3/level 4, serious adverse reactions or adverse events of special concern were reported. Incidences of adverse reactions were 1.47%(64/4 347) for 1-3-year-olds and 0.75%(36/4 822) for 4-12 year-olds(χ^(2)=11.16, P<0.001).Conclusion Adverse reactions were mild after a single dose of VarV vaccination among 1-12-year-old healthy children, and incidences of adverse reactions were less than expected.