重点人群同时接种23价肺炎球菌多糖疫苗和流感病毒裂解疫苗安全性评价  

Safety of co-vaccination with 23-valent pneumococcal polysaccharide vaccine and split influenza virus vaccine in key populations:an active surveillance study in 8 cities of Anhui province

作　　者：李涛 孙建文 卢希 徐海洋[3] 靳玉惠[4] 龚李敏[5] 程育慧 万江顺[7] 江良梁[8] 罗静 赵艳伟[2] 王斌冰[1] LI Tao;SUN Jianwen;LU Xi;XU Haiyang;JIN Yuhui;GONG Limin;CHENG Yuhui;WAN Jiangshun;JIANG Liangliang;LUO Jing;ZHAO Yanwei;WANG Binbing(Anhui Provincial Center for Disease Control and Prevention,Hefei 230601,China;Beijing Kexing Bioproducts Co.,Ltd.,Beijing 102601,China;Fuyang Center for Disease Control and Prevention,Fuyang 236000,China;Hefei Center for Disease Control and Prevention,Hefei 230091,China;Bengbu Center for Disease Control and Prevention,Bengbu 233000,China;Xuancheng Center for Disease Control and Prevention,Xuancheng 242000,China;Anqing Center for Disease Control and Prevention,Anqing 246000,China;Ma'anshan Center for Disease Control and Prevention,Ma’anshan 243000,China;Suzhou Center for Disease Control and Prevention,Suzhou 234000,China)

机构地区：[1]安徽省疾病预防控制中心,合肥230601 [2]北京科兴生物制品有限公司,北京102601 [3]阜阳市疾病预防控制中心,阜阳236000 [4]合肥市疾病预防控制中心,合肥230091 [5]蚌埠市疾病预防控制中心,蚌埠233000 [6]宣城市疾病预防控制中心,宣城242000 [7]安庆市疾病预防控制中心,安庆246000 [8]马鞍山市疾病预防控制中心,马鞍山243000 [9]宿州市疾病预防控制中心,宿州234000

出　　处：《中国公共卫生》2024年第7期809-816,共8页Chinese Journal of Public Health

基　　金：安徽省卫生健康科研项目(AHWJ2023A20369);2023年度安徽省疾病预防控制中心(安徽省公共卫生研究院)青年科研项目(JKQN20230203)。

摘　　要：目的评价在3岁及以上重点人群同时接种国产23价肺炎球菌多糖疫苗和流感病毒裂解疫苗的安全性,为制定23价肺炎多糖疫苗和流感疫苗免疫策略提供参考依据。方法于2021年10月—2023年2月在安徽省8个地市对3~<8岁儿童、8~<60岁患慢性基础疾病人群和≥60岁老年人群同时接种1针23价肺炎球菌多糖疫苗和1针流感病毒裂解疫苗,并观察接种后28 d内的安全性。采用“方舟免疫”手机程序和问卷相结合的方式进行主动监测,收集疫苗接种后的不良反应。结果本研究共主动监测5502名疫苗接种志愿者,3~<8岁2072人(患基础疾病者占1.45%)、8~<60岁患慢性基础疾病1598例,≥60岁1832人(患基础疾病者占37.61%)。不良反应均在接种后7 d内发生、发生率为2.67%,1、2和3级不良反应发生率分别为1.62%、0.93%和0.13%。局部和全身不良反应发生率分别为2.25%和1.00%,局部反应以疫苗接种部位疼痛为主,全身反应以发热为主。同时接种时肺炎疫苗的局部不良反应高于流感疫苗。3~<8、8~<60和≥60岁人群不良反应发生率分别为2.03%、3.25%和2.89%,差异无统计学意义(χ^(2)=5.741,P>0.05);各年龄组不良反应分级均以1级、2级为主。健康人群总体不良反应发生率为2.32%,患基础疾病人群总体不良反应发生率为3.15%,2组人群差异无统计学意义(χ^(2)=3.530,P>0.05),其中3~<8岁儿童、≥60岁健康人群与患基础疾病人群不良反应、发生等级差异均无统计学意义(均P>0.05)。结论在重点人群中同时接种国产23价肺炎球菌多糖疫苗和流感病毒裂解疫苗,不同年龄、不同健康状况接种人群均具有良好安全性,2种疫苗可同时接种。Objective To evaluate the safety of co-vaccination with domestic 23-valent pneumococcal polysaccharide vaccine(PPSV23)and split influenza virus vaccine(sFlu)in key populations aged 3 years and older and to provide a reference for formulating co-vaccination strategies.Methods The study participants were 5502 healthy and unhealthy(with chronic diseases)volunteers(including 2072 children aged 3–<8 years,1598 residents aged 8–<60 years,and 1832 elderly aged 60 years and older)vaccinated simultaneously with one dose of PPSV23(intramuscular injection into the deltoid muscle of the left upper arm)and one dose of sFlu(into the right upper arm)in 8 cities of Anhui province from October 2021 to February 2023.Active surveillance for adverse reactions within 28 days of co-vaccination with PPSV23 and sFlu was conducted among participants through active reporting via the Ark Immunization mobile application and telephone or home interviews by health care workers.Reported current/historic chronic diseases and observed adverse events after co-vaccination were categorized according to the Medical Dictionary for Regulatory Activities(MedDRA)and the Guiding Principles for the Classification of Adverse Events in Clinical Trials of Preventive Vaccines issued by the National Medical Products Administration.Results The prevalence of underlying chronic diseases was 1.45%,100.00%,and 37.61%in participants aged 3–<8,8–<60,and≥60 years,respectively.All adverse events occurred within 7 days of co-vaccination,with an incidence rate of 2.67%.The incidence rates of grade 1,2,and 3 adverse events were 1.62%,0.93%,and 0.13%,respectively.The incidence rates of local and systemic adverse events were 2.25%and 1.00%,respectively.Local reactions were mainly pain at the vaccination site,while systemic reactions were mainly fever.The incidence of local adverse events was higher for PPSV23 than for sFlu when administered at the same time.The incidence rates of adverse reactions in participants aged 3–<8,8–<60,and 60 years and older were 2.0

关 键 词：23价肺炎球菌多糖疫苗 流感病毒裂解疫苗 同时接种 安全性 

分 类 号：R186[医药卫生—流行病学]