Safety and immunogenicity of a quadrivalent inactivated subunit non-adjuvanted influenza vaccine: A randomized, double-blind, active-controlled phase 1 clinical trial

• DOI: 10.1016/j.vaccine.2021.05.070
• Publication Date: 2021-06-01T12:31:16Z
• Authors: Yanxia Wang; Yuhui Zhang; Haofei Wu; Lili Huang; Hailong Yu; Zhiqiang Xie; Huiping Zhang; Wei Zhang; Xiaofen Chen; Huan Zhang; Hongdong Zhang; Chunyu Jia; Shengli Xia; Shuai Wang
• Keywords: Trivalent influenza vaccine; Inactivated vaccine

Quadrivalent influenza inactivated vaccine (IIV4) is more likely to provide wider protection against yearly circulating viruses than trivalent (IIV3). In this study, a total of 320 participants were allocated four age cohorts (6–35 months, 3–8 years, 9–17 and ≥ 18 years; 80 participants/cohort) according their actual date birth. Participants in each cohort randomly assigned two groups receive intramuscular injection the trial or comparative one-dose (3–8 years,and years) schedule on day 0 two-dose months cohort) 28. The first objective evaluate safety immunogenicity full-dose subunit non-adjuvanted IIV4 (FD-subunit NAIIV4) we developed versus an active-control, China-licensed split-virion NAIIV4, people 3 years. second FD-subunit NAIIV4 half-dose (HD-subunit toddlers aged 6–35 months. Results showed that all adverse reactions noted rare, mild, self-limited. years cohorts, systemic less active control ([Systemic reaction rates (95%CI)], 15.0 (8.6–21.4) 19.2(12.1–26.2), p = 0.391). overall seroprotection efficacy after vaccination comparable between NAIIV4([Seroprotection H1N1, 99.2(81.3–100.0) 94.9(90.9–98.9), 0.117; H3N2, 81.7(74.7–88.6) 82.1(75.1–89.0), 0.939; BV, 75.8(68.2–83.5) 74.4(66.4–82.3), 0.793; BY, 94.2(90.0–98.4) 92.3(87.5–97.1), 0.568). Additionally, has better ([Total 37.5(18.5–56.5) 47.5(26.1–68.9), 0.366) ([Seroprotection 85(56.4–100.0) 75.7(47.6–100.0), 50(28.1–71.9) 29.7(12.2–47.3), 0.070; 75(48.2–100.0) < 0.001; 56.8(32.5–81.0), 0.091). As result, safe effective broader adequate during 2018–2019, which could be essential component global preventive strategy for pandemic.