Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell)

Summary

Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age. Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3\~17 and the age of 18\~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell). Study population:400 healthy people aged 3 to 17 years old, both male and female.

Timeline

Start

2021-11-04

Primary completion

2022-02-14

Completion

2023-04-06

Publications

• Gao L, Li Y, He P, Chen Z, Yang H, Li F, Zhang S, Wang D, Wang G, Yang S, Gong L, Ding F, Ling M, Wang X, Ci L, Dai L, Gao GF, Huang T, Hu Z, Ying Z, Sun J, Zuo X. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269-279. doi: 10.1016/S2352-4642(22)00376-5. Epub 2023 Feb 17.

Drugs

Indications