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

• Main Authors: Xiaoyuan Huang (Author), Ting Fan (Author), Li Li (Author), Xuanxuan Nian (Author), Jiayou Zhang (Author), Xuefen Gao (Author), Wei Zhao (Author), Wei Chen (Author), Zhaoqing Zhang (Author), Zhihao Yao (Author), Xixin Han (Author), Jinrong Shi (Author), Ying Wang (Author), Haihe Bian (Author), Nianmin Shi (Author), Xinguo Li (Author), Kai Duan (Author), Guohua Li (Author), Xiaoming Yang (Author)
• Format: Book
• Published: Taylor & Francis Group, 2022-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 2164-5515; 2164-554X; 10.1080/21645515.2022.2079924
• Keywords: quadrivalent influenza vaccine; phase iii trial; safety; immunogenicity; Immunologic diseases. Allergy; RC581-607; Therapeutics. Pharmacology; RM1-950
• Source: Human Vaccines & Immunotherapeutics, Vol 18, Iss 5 (2022)

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