Immunogenicity and safety of an egg culture-based quadrivalent inactivated non-adjuvanted subunit influenza vaccine in subjects ≥3 years: A randomized, multicenter, double-blind, active-controlled phase III, non-inferiority trial

Zhang, Yuhui; Wang, Yanxia; Jia, Chunyu; Li, Guangfu; Zhang, Wei; Li, Qin; Chen, Xiaofen; Leng, Wenna; Huang, Lili; Xie, Zhiqiang; Zhang, Huiping; You, Wangyang; An, Rui; Jiang, Hongyan; Zhao, Xuezhi; Cheng, Shirley; Tan, Jiebing; Cui, Weiyang; Gao, Feilong; Lü, Wei; Wang, Yuping; Yang, Yongli; Xia, Shengli; Wang, Shuai

doi:10.1016/j.vaccine.2022.06.078

Cited by 2 publications

(1 citation statement)

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“…The two-dose schedule is, therefore, considered the best strategy to prevent influenza [ 13 ]. Zhang et al administered a second booster dose to children aged 3–8 years on day 28 after the first dose of vaccine and found that the booster provided better seroprotection to the children compared with only one dose of vaccine [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

Exploratory Study of the Phase IV Immunization Schedule of Quadrivalent Influenza Split-Virion Vaccine in Children Aged 3–8 Years

Li,

Kou,

Liu

et al. 2024

Vaccines

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This study explored the optimum immunization schedule for the quadrivalent influenza split-virion vaccine containing influenza A strains (H1N1 and H3N2) and B lineage strains (Yamagata and Victoria) in children aged 3–8 years. The 652 participants enrolled were divided into two groups based on a history of influenza immunization (IH group) or no history of influenza immunization (NH group). The groups were administered a two-dose immunization schedule on days 0 and 30. In the NH group, on day 30 after the first dose, the positive rates of influenza hemagglutination-inhibition antibodies of strains H1N1, H3N2, BV, and BY were 85.85%, 71.70%, 65.27% and 60.45%, respectively. The positive rates of BV and BY failed to meet the absolute criteria for evaluating the immunogenicity of influenza vaccine in the population aged 3–60 years (for each strain antibody). On day 30 after the second dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the immunogenicity acceptable criteria. In the IH group, on day 30 after the first dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the acceptable criteria for immunogenicity. The incidence rates of adverse reactions (vaccine-related adverse events) from the first dose up until 30 days after the second dose were 20.80% in the IH group and 19.50% in the NH group. Only two Grade 3 adverse reactions (fever: temperature ≥ 39.5 °C, swelling: area ≥ 50% of the injection site area) occurred in the IH group, and no Grade 3 adverse reactions occurred in the NH group. No serious adverse reactions occurred in either group. We conclude that for the NH group, two doses of quadrivalent influenza vaccine should be administered, and for the IH group, a one-dose regimen is acceptable.

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Section: Discussionmentioning

confidence: 99%