NCT04510207: COVID-19

A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above

Completed Phase 3 Last updated 18 June 2023

What this trial tests

Phase 3 trial testing Inactivated SARS-CoV-2 Vaccine (Vero cell) in COVID-19 in 44,101 participants. Completed in 31 December 2021.

Timeline

16 July 2020

Primary endpoint
16 June 2021

31 December 2021

Quick facts

Lead sponsor	China National Biotec Group Company Limited
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	44,101
Start date	16 July 2020
Primary completion	16 June 2021
Estimated completion	31 December 2021
Sites	6 locations across Jordan, Egypt, Bahrain, United Arab Emirates

Drugs / interventions tested

• Inactivated SARS-CoV-2 Vaccine (Vero cell)
• Inactivated SARS-CoV-2 Vaccine (Vero cell)
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

China National Biotec Group Company Limited — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress of the COVID-19 vaccine effort: viruses, vaccines and variants versus efficacy, effectiveness and escape.
   Tregoning JS, Flight KE, Higham SL, Wang Z, et al · · 2021 · cited 827× · PMID 34373623 · DOI 10.1038/s41577-021-00592-1
2. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial.
   Al Kaabi N, Zhang Y, Xia S, Yang Y, et al · · 2021 · cited 631× · PMID 34037666 · DOI 10.1001/jama.2021.8565
3. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
   Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w
4. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
   Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
5. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
6. Vaccines for COVID-19.
   Tregoning JS, Brown ES, Cheeseman HM, Flight KE, et al · · 2020 · cited 154× · PMID 32935331 · DOI 10.1111/cei.13517
7. Evaluation of the safety profile of COVID-19 vaccines: a rapid review.
   Wu Q, Dudley MZ, Chen X, Bai X, et al · · 2021 · cited 151× · PMID 34315454 · DOI 10.1186/s12916-021-02059-5
8. An overview of current COVID-19 vaccine platforms.
   Nagy A, Alhatlani B. · · 2021 · cited 113× · PMID 33936564 · DOI 10.1016/j.csbj.2021.04.061