A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years

Summary

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. For those aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose of influenza vaccine. For those who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine, they require 2 dose of influenza vaccine. but the evidence on how to select vaccine doses for quadrivalent influenza vaccine is limited in China. The study is a prospective, open-label comparison of the immunogenicity and reactogenicity of 1 versus 2 doses of an inactivated quadrivalent influenza vaccine in subjects of 3-8 years old with different history of influenza vaccination.

Timeline

Start

2021-09-19

Primary completion

2021-11-23

Completion

2022-04-30

Publications

• Wen F, Liu S, Zhou L, Zhu Y, Wang W, Wei M, Xu X, Liu Y, Shuai Q, Yu J, Jing P, Li J, Zhu F. Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories. Hum Vaccin Immunother. 2025 Dec;21(1):2468074. doi: 10.1080/21645515.2025.2468074. Epub 2025 Feb 24.

Drugs

Indications