四价流感病毒裂解疫苗上市后安全性及免疫原性评价

Post-marketing evaluation on safety and immunogenicity of influenza virus vaccine(split virion),inactivated,quadrivalent

目的评价四价流感病毒裂解疫苗[influenza vaccine(split virion),inactivated,quadrivalent,IIV4]上市后的安全性和免疫原性。方法选择2020年9月—2021年6月于贵州、福建及湖南省接种1剂IIV4、年龄≥3岁的人群为研究对象,受试者分别于接种前和接种后30 d静脉采血5.0 mL,分离血清,采用血凝抑制试验(hemmagglution inhibition test,HI)检测4种(H1N1、H3N2、BY和BV)血清抗体水平,主动监测接种后0~7 d的不良事件。结果410人完成入组及接种纳入安全性分析,研究期间脱落9人,401人纳入免疫原性分析。H1N1、H3N2、BY和BV抗体阳转率的95%可信区间(CI)下限均超过40%,接种后保护率的95%CI下限均超过70%,抗体几何平均增长倍数(GMI)的95%CI下限均超过2.5。研究期间共发生103例不良事件,不良事件总发生率为25.12%,局部不良事件以接种部位疼痛、硬结、红、肿胀为主,全身不良事件以发热、腹泻、嗜睡为主,严重程度以1级(轻度)为主。结论IIV4上市后具有良好的安全性和免疫原性。

Objective To evaluate the post-marketing safety and immunogenicity of influenza virus vaccine(split virion),inactivated,quadrivalent(IIV4).Methods The populations immunized with a single dose of IIV4,in Guizhou,Fujian and Hunan Provinces,China from September 2020 to June 2021 at ages of not less than 3 years,were selected as subjects,of whom the serum samples were collected before and 30 d after immunization and determined for antibody levels against influenza virus of subtypes H1 N1,H3 N2,BY and BV by hemmagglution inhibition(HI)test.Meanwhile,the adverse events(AEs)0~7 d after immunization were monitored.Results A total of 410 participants were enrolled and included in safety analysis,of whom 401 were included in immunogenicity analysis.The lower limits of 95%CI of seroconversion rates against H1 N1,H3 N2,BY and BV were more than 40%,while those of seroprotection rates were more than 70%,and the geometric mean increases(GMIs)were more than 2.5.The overall incidence rate of was 25.12%(103/410).The local AEs were mainly pain,induration,redness and swollen in inoculation site,while the systemic AEs were mainly fever,diarrhea and drowsiness.Most of the AEs were mild.Conclusion IIV4 showed good post-marketing safety and immunogenicity.