drugset / Trial / NCT05128643

Clinical Study on the Immune Program of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell)

NCT05128643 ↗

Non-randomizedParallel-groupOpen-labelPrevention

Summary

Popular topic:Clinical study on the immune program of recombinant Novel Coronavirus (COVID-19) vaccine (CHO cell). Research purpose:Main purpose: To evaluate the immunogenicity of recombinant novel coronavirus vaccine (CHO cells) inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and over. Secondary purpose: To evaluate the safety of the investigational vaccine in people aged 18 and above. Overall design: In this study, recombinant novel coronavirus vaccine (CHO cells) is inoculated at 0,1,6 months or 0,1,4 months in persons aged 18 years and older to evaluate the immunogenicity and safety. Study population:The study involved people 18 years of age and older. Test groups:A total of 300 subjects were enrolled, including 221 in the 18-59 age group and 79 in the ≥60 age group. Three doses of experimental vaccine were administered according to the 0,1,6 month immunization schedule (Study No. 001-150) or 0,1,4 months immunization schedule (Study No. 151-300).

Timeline

Start
2021-09-17
Primary completion
2022-04-12
Completion
2022-10-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant novel coronavirus vaccine (CHO cell) Vaccine 25 ug Intramuscular

Indications