1. 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.
- Author
-
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, Xue, Cheng, Siyan, Tan, Jiebing, Cui, Weiyang, Gao, Feilong, and Lu, Weifeng
- Subjects
- *
INFLUENZA vaccines , *IMMUNE response , *VACCINE trials , *CLINICAL trial registries , *VACCINE immunogenicity , *VETERINARY vaccines , *INFLUENZA - Abstract
• The trial vaccine was safe in subjects ≥ 3 years. • The immunogenicity of trial vaccine was non-inferior to the comparator in ≥ 3 years subjects. • Two-dose vaccine series with the trial vaccine is safe and can trigger a stronger immune response than that of one-dose in 3–8 years subjects. Subunit influenza vaccine only formulated with surface antigen proteins has better safety profiles relative to split-virion influenza vaccine. Compared to the traditional quadrivalent split-virion influenza vaccine, a novel quadrivalent subunit influenza vaccine is urgently needed in China. We completed a phase 3, randomized, double-blind, active-controlled, non-inferiority clinical study at two sites in Henan Province, China. Eligible volunteers were split into four age cohorts (3–8 years, 9–17 years, 18–64 years, and ≥ 65 years, based on their dates of birth) and randomly assigned (1:1) to the subunit and the split-virion ecNAIIV4 groups. All volunteers were intramuscularly administered a single vaccine dose at baseline, and children aged 3–8 years received a boosting dose at day 28. And the immune response was evaluated by measuring hemagglutinin-inhibition antibody titers against the four vaccine strains in blood samples. Safety profiles had nonsignificant differences between the study groups in ≥ 3 years cohort. Most adverse reactions post-vaccination, both local and systemic, were mild to moderate and resolved within 3 days. And no serious adverse events occurred. The immunogenicity of the trial vaccine was non-inferior to the comparator. Further, a two-dose vaccine series can provide better seroprotection than that of a one-dose series in children aged 3–8 years, with clinically acceptable safety profiles. Clinical Trials Registration. ChiCTR2100049934. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF