NCT04551547

Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19

Completed Phase 1, PHASE2 Last updated 2 October 2023

What this trial tests

Phase 1, PHASE2 trial testing Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 in COVID-19 in 552 participants. Completed in 8 February 2023.

Timeline

31 October 2020

Primary endpoint
30 April 2021

8 February 2023

Quick facts

Lead sponsor	Sinovac Research and Development Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	552
Start date	31 October 2020
Primary completion	30 April 2021
Estimated completion	8 February 2023
Sites	1 location across China

Drugs / interventions tested

• Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 — full drug profile →
• Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 — full drug profile →
• Two doses of placebo at the schedule of day 0,28 — 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 3 to 17, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blinded, and placebo controlled phase 1\&2 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 safety and immunogenicity of the experimental vaccine in healthy children and adolescents aged 3-17 years

Publications & conference data

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

1. COVID-19 vaccine development: milestones, lessons and prospects.
   Li M, Wang H, Tian L, Pang Z, et al · · 2022 · cited 298× · PMID 35504917 · DOI 10.1038/s41392-022-00996-y
2. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial.
   Han B, Song Y, Li C, Yang W, et al · · 2021 · cited 245× · PMID 34197764 · DOI 10.1016/s1473-3099(21)00319-4
3. 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
4. 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
5. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
6. COVID-19: Coronavirus Vaccine Development Updates.
   Zhao J, Zhao S, Ou J, Zhang J, et al · · 2020 · cited 136× · PMID 33424848 · DOI 10.3389/fimmu.2020.602256
7. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
   Luxi N, Giovanazzi A, Capuano A, Crisafulli S, et al · · 2021 · cited 98× · PMID 34739716 · DOI 10.1007/s40264-021-01131-6
8. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406