Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

Phase 4 Completed 270 enrolled Sinovac Research and Development Co., Ltd.

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Timeline

Start: 2021-07-09
Primary completion: 2021-10-31
Completion: 2022-01-31

Publications

Xu Q, Lu X, Liu X, Zhao Y, Sun D, Cao Q, Liu H, Yang T, Song Y, Lv J, Xiong P, Li J, Sun J, Xie M, Gao Y, Zhang L. Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial. Front Immunol. 2023 May 31;14:1122651. doi: 10.3389/fimmu.2023.1122651. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	23-valent pneumococcal polysaccharide vaccine	Vaccine	25 ug	—
Subject	Inactivated COVID-19 vaccine	Vaccine	600 unknown	—
Comparator	Inactivated hepatitis A vaccine	Vaccine	500 unknown	—

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

Summary

Timeline

Publications

Drugs

Indications