2018-2021年湖北省<3岁儿童13价肺炎球菌多糖结合疫苗与轮状病毒疫苗联合接种不良反应评价

Adverse reactions following co-administration of 13-valent pneumococcal polysaccharide conjugate vaccine and rotavirus vaccine among children under 3 years old in Hubei province,2018-2021

目的评价<3岁儿童13价肺炎球菌多糖结合疫苗(Pneumococcal conjugate vaccine,PCV13)与轮状病毒疫苗(Rotavirus vaccine,RV)联合接种的不良反应。方法通过湖北省和中国免疫规划信息管理系统分别收集湖北省2018-2021年<3岁儿童PCV13和RV接种剂次数和不良反应报告数据。采用Poisson回归模型计算经年龄、性别和季度调整的PCV13和RV联合/单独接种不良反应报告发生率及其95%CI。结果PCV13与RV联合接种、PCV13单独接种、RV单独接种不良反应报告发生率及其95%CI(/10万剂)分别为61.64(44.28-85.79)、57.13(51.49-63.37)、23.88(21.66-26.33),其中一般反应分别为57.82(40.94-81.66)、52.76(47.36-58.78)、21.17(19.08-23.48),异常反应分别为2.69(0.66-10.97)、3.65(2.42-5.49)、1.70(1.18-2.45)。结论<3岁儿童PCV13和RV联合或单独接种不良反应报告发生率均在预期范围内,联合接种未增加不良反应发生风险。

Objective To evaluate adverse reactions following co-administration of 13-valent pneumococcal conjugate vaccine(PCV13)and rotavirus vaccine(RV)in children under 3 years of age.Methods We obtained data on PCV13 and RV doses administered and reported adverse reactions among children under 3 years of age in Hubei province during 2018-2021 from the Hubei and China immunization information management systems.We used Poisson regression models to calculate incidence rates(95%CI)of reported adverse reactions following simultaneous and standalone vaccination with PCV13 and RV,adjusted by age,gender,and quarter of the year.Results Incidence rates(95%CI)per 100000 doses of reported adverse reactions following simultaneous administration of PCV13 and RV,standalone PCV13,and standalone RV vaccination were 61.64(44.28-85.79),57.13(51.49-63.37),and 23.88(21.66-26.33),with 57.82(40.94-81.66),52.76(47.36-58.78),and 21.17(19.08-23.48)being common reactions and 2.69(0.66-10.97),3.65(2.42-5.49),and 1.70(1.18-2.45)being rare reactions.Conclusions The reported incidences of adverse reactions among children under 3 years old following simultaneous or standalone PCV13 and RV vaccination were within the expected range.Coadministration of the two vaccines did not increase risk of adverse reactions.