tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2022 Jun 17;2079924.
doi: 10.1080/21645515.2022.2079924. Online ahead of print.
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
Xiaoyuan Huang[SUP] 1 [/SUP], Ting Fan[SUP] 2 [/SUP], Li Li[SUP] 3 [/SUP], Xuanxuan Nian[SUP] 1 4 [/SUP], Jiayou Zhang[SUP] 1 4 [/SUP], Xuefen Gao[SUP] 2 [/SUP], Wei Zhao[SUP] 1 4 [/SUP], Wei Chen[SUP] 1 4 [/SUP], Zhaoqing Zhang[SUP] 5 [/SUP], Zhihao Yao[SUP] 5 [/SUP], Xixin Han[SUP] 1 4 [/SUP], Jinrong Shi[SUP] 1 4 [/SUP], Ying Wang[SUP] 1 4 [/SUP], Haihe Bian[SUP] 6 [/SUP], Nianmin Shi[SUP] 3 [/SUP], Xinguo Li[SUP] 1 4 [/SUP], Kai Duan[SUP] 1 4 [/SUP], Guohua Li[SUP] 2 [/SUP], Xiaoming Yang[SUP] 4 7 [/SUP]
Affiliations
Abstract
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.
Keywords: Quadrivalent influenza vaccine; immunogenicity; phase III trial; safety.
. 2022 Jun 17;2079924.
doi: 10.1080/21645515.2022.2079924. Online ahead of print.
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
Xiaoyuan Huang[SUP] 1 [/SUP], Ting Fan[SUP] 2 [/SUP], Li Li[SUP] 3 [/SUP], Xuanxuan Nian[SUP] 1 4 [/SUP], Jiayou Zhang[SUP] 1 4 [/SUP], Xuefen Gao[SUP] 2 [/SUP], Wei Zhao[SUP] 1 4 [/SUP], Wei Chen[SUP] 1 4 [/SUP], Zhaoqing Zhang[SUP] 5 [/SUP], Zhihao Yao[SUP] 5 [/SUP], Xixin Han[SUP] 1 4 [/SUP], Jinrong Shi[SUP] 1 4 [/SUP], Ying Wang[SUP] 1 4 [/SUP], Haihe Bian[SUP] 6 [/SUP], Nianmin Shi[SUP] 3 [/SUP], Xinguo Li[SUP] 1 4 [/SUP], Kai Duan[SUP] 1 4 [/SUP], Guohua Li[SUP] 2 [/SUP], Xiaoming Yang[SUP] 4 7 [/SUP]
Affiliations
- PMID: 35714276
- DOI: 10.1080/21645515.2022.2079924
Abstract
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.
Keywords: Quadrivalent influenza vaccine; immunogenicity; phase III trial; safety.