NCT04617483

Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults

Completed Phase 3 Last updated 27 July 2021

What this trial tests

Phase 3 trial testing Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in Covid19 in 1,040 participants. Completed in 31 May 2021.

Timeline

31 October 2020

Primary endpoint
28 November 2020

31 May 2021

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	1,040
Start date	31 October 2020
Primary completion	28 November 2020
Estimated completion	31 May 2021
Sites	1 location across China

Drugs / interventions tested

• Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 — full drug profile →
• Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 — full drug profile →
• Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

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

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.

Publications & conference data

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

1. Viral targets for vaccines against COVID-19.
   Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0
2. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial.
   Wu Z, Hu Y, Xu M, Chen Z, et al · · 2021 · cited 398× · PMID 33548194 · DOI 10.1016/s1473-3099(20)30987-7
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. SARS-CoV-2 (Covid-19) vaccines structure, mechanisms and effectiveness: A review.
   Fathizadeh H, Afshar S, Masoudi MR, Gholizadeh P, et al · · 2021 · cited 97× · PMID 34403674 · DOI 10.1016/j.ijbiomac.2021.08.076
6. Fast-spreading SARS-CoV-2 variants: challenges to and new design strategies of COVID-19 vaccines.
   Zhou W, Wang W. · · 2021 · cited 97× · PMID 34108440 · DOI 10.1038/s41392-021-00644-x
7. 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
8. Nanocarrier vaccines for SARS-CoV-2.
   Machhi J, Shahjin F, Das S, Patel M, et al · · 2021 · cited 58× · PMID 33428995 · DOI 10.1016/j.addr.2021.01.002