四价流感病毒裂解疫苗和23价肺炎球菌多糖疫苗在≥60岁老年人中同时接种的安全性评价  

Safety evaluation of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older

作　　者：朱中奎[1] 卢希 唐万琴[1] 孙建文 申璐 陈秋兰[2] 刘华先 于扬 顾维 赵艳伟 解燕[1] Zhu Zhongkui;Lu Xi;Tang Wanqin;Sun Jianwen;Shen Lu;Chen Qiulan;Liu Huaxian;Yu Yang;Gu Wei;Zhao Yanwei;Xie Yan(Taizhou Center for Disease Control and Prevention,Taizhou 225300,China;Sinovac Biotech Co.,Ltd.,Beijing 100085,China;Sinovac Life Sciences Co.,Ltd.,Beijing 102601,China)

机构地区：[1]泰州市疾病预防控制中心,泰州225300 [2]北京科兴生物制品有限公司,北京100085 [3]北京科兴中维生物技术有限公司,北京102601

出　　处：《中华预防医学杂志》2023年第9期1412-1417,共6页Chinese Journal of Preventive Medicine

摘　　要：目的分析60岁及以上老年人群同时接种四价流感病毒裂解疫苗与23价肺炎球菌多糖疫苗后的安全性。方法于2021年11月至2022年5月,在江苏省泰州市招募符合标准的60岁及以上老年人群,最终纳入2461名受试者。每名受试者同时接种1剂四价流感病毒裂解疫苗和1剂23价肺炎球菌多糖疫苗,并在接种后28 d内进行安全性观察。采用主动填报和定期回访的方式收集受试者接种疫苗后的安全性信息。结果2461名受试者完成两种疫苗的同时接种,并完成了接种后28 d的安全性观察随访。受试者年龄为(70.66±6.18)岁;男性占54.61%(1344名);均为汉族居民;罹患基础疾病者占22.51%(554名)。同时接种后0~28 d内,总体不良反应的发生率为2.07%(51/2461),主要为1级不良反应[1.83%(45/2461)],未观察到4级及以上不良反应以及与疫苗相关的严重不良事件。局部不良反应发生率为0.98%(24/2461),主要症状为接种部位疼痛[0.93%(23/2461)];全身不良反应的发生率为1.42%(35/2461),其主要症状为发热[0.85%(21/2461)]。基础疾病组和健康组受试者的总体不良反应发生率分别为2.53%(14/554)和1.94%(37/1907),局部不良反应发生率分别为1.62%(9/554)和0.79%(15/1907),全身不良反应发生率分别为1.44%(8/554)和1.42%(27/1907),组间差异均无统计学意义(均P>0.05)。结论老年人同时接种四价流感病毒裂解疫苗与23价肺炎球菌多糖疫苗后的安全性较好。ObjectiveTo evaluate the safety of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older.MethodsFrom November 2021 to May 2022,eligible participants aged 60 years and older were recruited in Taizhou City,Jiangsu Province,China,and a total of 2461 participants were ultimately enrolled in this study.Each participant simultaneously received one dose of quadrivalent influenza split virion vaccine and one dose of 23-valent pneumococcal polysaccharide vaccine.The safety was observed within 28 days after vaccination.Safety information was collected through voluntary reporting and regular follow-ups.ResultsAll 2461 participants completed the simultaneous administration of both vaccines and the safety follow-ups for 28 days after vaccination.The mean age of the participants was(70.66±6.18)years,with 54.61%(1344)being male,and all participants were Han Chinese residents.About 22.51%(554)of the participants had underlying medical conditions.The overall incidence of adverse reactions within 0-28 days after simultaneous vaccination was 2.07%(51/2461),mainly consisting of Grade 1 adverse reactions[1.83%(45/2461)],with no reports of Grade 4 or higher adverse reactions or vaccine-related serious adverse events.The incidence of local adverse reactions was 0.98%(24/2461),primarily presenting as pain at the injection site[0.93%(23/2461)].The incidence of systemic adverse reactions was 1.42%(35/2461),with fever[0.85%(21/2461)]being the main symptom.In the group with underlying medical conditions and the healthy group,their overall incidence of adverse reactions was 2.53%(14/554)and 1.94%(37/1907),respectively.The incidence of local adverse reactions in the two groups was 1.62%(9/554)and 0.79%(15/1907),respectively,and the incidence of systemic adverse reactions was 1.44%(8/554)and 1.42%(27/1907),respectively,with no statistically significant differences between them(all P>0.05).ConclusionIt is safe for adults aged 60 years and o

关 键 词：疫苗 老年人 临床试验 同时接种 安全性 

分 类 号：R186[医药卫生—流行病学]