【摘要】 目的 分析1～12岁儿童水痘疫苗(Varicella vaccine, VarV)预防接种不良反应和水痘突破病例。方法 在安徽省5个县区招募1～12岁适龄儿童接种1剂次VarV,随访接种后42 d内不良反应和3年内水痘突破病例，分析不良反应发生率和水痘突破病例发病密度。结果 共招募受试者29 624例，接种1剂次VarV后发生不良反应180例，总发生率为6.08‰,其中1～3岁、4～6岁、7～12岁分别为7.42‰、5.94‰、5.41‰,既往有、无VarV免疫史分别为6.19‰、5.90‰,局部、全身不良反应分别为3.48‰、2.73‰,1级、2级、3级、4级不良反应分别为4.56‰、1.45‰、0.07‰、0.00‰。受试者水痘突破病例发病率为0.91‰(27例),总发病密度为0.32/千人年，其中1～3岁、4～6岁、7～12岁分别为0.17/千人年、0.50/千人年、0.18/千人年。结论 1～12岁儿童接种VarV后不良反应发生率低且症状轻，接种后3年内仍可发生一定水平的水痘突破病例。更多还原

【Abstract】 Objective To evaluate the incidence of adverse reactions and breakthrough cases after varicella vaccination in children aged 1-12 years.Methods We recruited eligible children aged 1 to 12 years in 5 counties and districts of Anhui province to receive a single dose of VarV and be monitored for adverse reactions within 42 days after vaccination and for varicella breakthrough cases for 3 years after vaccination to analyze the incidence of adverse reactions and the occurrence of breakthrough cases.Results A total of 29 624 participants completed the safety observation; the overall incidence of adverse reactions was 6.08‰(180 cases). Incidences were 7.42‰ for ages 1-3 years, 5.94‰ for ages 4-6 years, and 5.41‰ for ages 7-12 years. In subjects with and without a previous VarV vaccination history, incidences were 6.19‰ and 5.90‰. Incidences of local and systemic adverse reactions were 3.48‰ and 2.73‰. Incidences of grade 1, 2, 3, and 4 adverse reactions were 4.56‰, 1.45‰, 0.07‰, and 0.00‰. The varicella breakthrough rate was 0.91‰(27 cases), with an incidence density of 0.32 per 1 000 person-years. Incidence densities in the 1-3, 4-6, and 7-12 age groups were 0.17, 0.50, and 0.18 per 1 000 person-years.Conclusions The incidence of adverse reactions after receiving VarV vaccine in children aged 1 to 12 years was low and symptoms were mild. Some breakthrough cases may occur within three years after vaccination.更多还原