Safety and immunogenicity of a quadrivalent, inactivated, split-virion influenza vaccine (IIV4-W) in healthy people aged 3-60 years: a phase III randomized clinical noninferiority trial

• DOI: 10.1080/21645515.2022.2079924
• Publication Date: 2022-06-17T19:09:41Z
• Authors: Xiaoyuan Huang; Ting Fan; Li Li; Xuanxuan Nian; Jiayou Zhang; Xuefen Gao; Wei Zhao; Wei Chen; Zhaoqing Zhang; Zhihao Yao; Xixin Han; Jinrong Shi; Ying Wang; Haihe Bian; Nianmin Shi; Xinguo Li; Kai Duan; Guohua Li; Xiaoming Yang
• Keywords: Seroconversion

Background A quadrivalent split influenza vaccine IIV4-W against both and B viruses is urgently needed.Methods To evaluate the safety immunogenicity of in people aged 3–60 years, 2400 participants recruited a double-blind phase III trial were randomly assigned to IIV4-W, TIV1 TIV2 groups. The indicators measured at 28 days postvaccination for 180 follow-up.Results Adverse events (AEs) occurred 162 (20.28%), 116 (14.55%) 123 (15.41%) groups, respectively. All these AEs mild self-limiting, no serious related vaccines observed. elicited non-inferior immune response matched strains (the lower limit 95% CI GMT ratio >0.67, SCR SPR difference >-10%) superior additional >1.5, >10%) versus TIVs. confidence interval increase fold, seroconversion rate seroprotection exceeded 2.5, 40% 70% four respectively.Conclusions was noninferior TIV-matched strain. safe high antibody titers.