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

A quadrivalent split influenza vaccine IIV4-W against both influenza A and B viruses is urgently needed. 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 TIV...

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Published in:Human vaccines & immunotherapeutics 2022-11, Vol.18 (5), p.2079924-2079924
Main Authors: Huang, Xiaoyuan, Fan, Ting, Li, Li, Nian, Xuanxuan, Zhang, Jiayou, Gao, Xuefen, Zhao, Wei, Chen, Wei, Zhang, Zhaoqing, Yao, Zhihao, Han, Xixin, Shi, Jinrong, Wang, Ying, Bian, Haihe, Shi, Nianmin, Li, Xinguo, Duan, Kai, Li, Guohua, Yang, Xiaoming
Format: Article
Language:English
Subjects:
immunogenicity
Influenza – Research Paper
phase III trial
Quadrivalent influenza vaccine
safety
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Summary:A quadrivalent split influenza vaccine IIV4-W against both influenza A and B viruses is urgently needed. 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. 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. 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.
ISSN:2164-5515
2164-554X
DOI:10.1080/21645515.2022.2079924