Efficacy, Safety and Immunogenicity Study of the Recombinant Two-component COVID-19 Vaccine (CHO Cell)(Recov)

PHASE3CompletedINTERVENTIONAL
Enrollment

7,623

Participants

Timeline

Start Date

October 31, 2022

Primary Completion Date

September 4, 2023

Study Completion Date

December 29, 2023

Conditions
COVID-19
Interventions
BIOLOGICAL

Recombinant two-component COVID-19 vaccine (CHO cell)

Before reconstitution: Lyophilized powder for reconstitution in single-use vials After reconstitution with BFA03 adjuvant: Milk-white solution with no visible foreign matter

BIOLOGICAL

Placebo

"Before reconstitution:~Lyophilized powder for reconstitution in single-use vials~After reconstitution with BFA03 adjuvant:~Milk-white solution with no visible foreign matter"

Trial Locations (11)

Unknown

B.P. Koirala Institute of Health Sciences, Dharān

Aramil City Hospital, Aramil

LLC Medical Service solutions, Izhevsk

"'Federal State Budgetary Scientific Institution Russian Scientific Centre of Surgery named after academician B.V. Petrovsky", Moscow

"'Joint Stock Company Clinical and diagnostic center Euromedservice", Moscow

"State Regional Budgetary Institution of Healthcare Murmansk Regional Clinical Hospital named after P.A. Bayandin", Murmansk

LLC Professorskaya klinika, Perm

UZI 4D Clinic LLC, Pyatigorsk

Klinika Zvyezdnaya LLC, Saint Petersburg

"Limited Liability Company Sfera-Med", Saint Petersburg

Research Center Eco-safety, Saint Petersburg

All Listed Sponsors
lead

Jiangsu Rec-Biotechnology Co., Ltd.

INDUSTRY