NCT04992260

Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents

Completed Phase 3 Last updated 16 October 2023

What this trial tests

Phase 3 trial testing Inactivated COVID-19 Vaccine in COVID-19 in 11,349 participants. Completed in 31 May 2023.

Timeline

10 September 2021

Primary endpoint
31 May 2023

31 May 2023

Quick facts

Lead sponsor	Sinovac Research and Development Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	11,349
Start date	10 September 2021
Primary completion	31 May 2023
Estimated completion	31 May 2023
Sites	38 locations across Philippines, Chile, South Africa, Malaysia

Drugs / interventions tested

• Inactivated COVID-19 Vaccine — full drug profile →
• Controlled vaccine — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Sinovac Research and Development Co., Ltd. — full company profile →

Who can join

Adults 6 Months to 17, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.

Publications & conference data

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

1. 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
2. Safety and efficacy of COVID-19 vaccines in children and adolescents: A systematic review of randomized controlled trials.
   Tian F, Yang R, Chen Z. · · 2022 · cited 47× · PMID 35705969 · DOI 10.1002/jmv.27940
3. Reduced Immune Response to Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Cohort of Immunocompromised Patients in Chile.
   Balcells ME, Le Corre N, Durán J, Ceballos ME, et al · · 2022 · cited 33× · PMID 35255140 · DOI 10.1093/cid/ciac167
4. Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children.
   Soto JA, Melo-González F, Gutierrez-Vera C, Schultz BM, et al · · 2022 · cited 23× · PMID 36383021 · DOI 10.1128/mbio.01311-22
5. A Review of Inactivated COVID-19 Vaccine Development in China: Focusing on Safety and Efficacy in Special Populations.
   Hu L, Sun J, Wang Y, Tan D, et al · · 2023 · cited 22× · PMID 37376434 · DOI 10.3390/vaccines11061045
6. Nanoparticles in clinical trials of COVID-19: An update.
   Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
7. SARS-CoV-2 vaccine booster in solid organ transplant recipients previously immunised with inactivated versus mRNA vaccines: A prospective cohort study.
   Dib M, Le Corre N, Ortiz C, García D, et al · · 2022 · cited 18× · PMID 36185969 · DOI 10.1016/j.lana.2022.100371
8. Analysis of the Protective Efficacy of Approved COVID-19 Vaccines Against Various Mutants.
   Li C, Guo Y, Fang Z, Zhang H, et al · · 2022 · cited 17× · PMID 35572594 · DOI 10.3389/fimmu.2022.804945