Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6–35 months of age in China: A randomized, double-blind, clinical trial

作者：Shilei Wang, Yanxia Wang, Dandan Chen, Wenting Xu, Peng Duan, Wei Ji, Weijun Liu, Weijin Huang, Bing Wu, Wenqing Chai, Chenyan Zhao, Yongli Yang, Jian Luo, Dongyang Zhao, Xiuling Li · 发表于：Human Vaccines & Immunotherapeutics · 年份：2024 · DOI：10.1080/21645515.2024.2425149 · 被引用次数：6 · 研究领域：Influenza Virus Research Studies、Respiratory viral infections research、SARS-CoV-2 and COVID-19 Research

A half-dose influenza vaccine (7.5 μg hemagglutinin per strain) has been used for children under 3 years of age for a long time. However, several studies indicate that a full-dose influenza vaccine (15 μg hemagglutinin per strain) may bring more benefit to this population without increasing the risk of adverse reactions. We conducted a clinical study in children aged 6-35 months in China. Participants were randomized to receive two doses of full-dose quadrivalent influenza vaccine (F-QIV), half-dose quadrivalent vaccine (H-QIV), and two half-dose trivalent vaccines (H-TIV) in a 2:2:1:1 ratio. The safety and tolerability profile of the vaccine was evaluated for 6 months postvaccination. Hemagglutination inhibition (HI) antibody titers were measured for immunogenicity assessment. The primary objective was to assess whether the results of all vaccines met the criteria. A total of 1,980 participants were enrolled in the study. Both H-QIV and F-QIV were well tolerated after vaccination. Although the geometric mean increase (GMI), seroconversion rate (SCR), and seroprotection rate (SPR) for both H-QIV and F-QIV were achieved by the criteria, superior immunogenicity in terms of geometric mean titer (GMT) ratio was observed in F-QIV to H-QIV for A/H3N2 (GMT ratio (95% CI) of 1.37 (1.11 ~ 1.68)) and B/Yamagata (1.21 (1.05 ~ 1.39)). Antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. In conclusion, F-QIV and H-QIV were both safe and immun...