NCT05046548View on ClinicalTrials.gov

This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 3, 2020

Primary Completion Date

October 15, 2020

Study Completion Date

October 1, 2021

Conditions
Coronavirus InfectionsVaccine
Interventions
BIOLOGICAL

Vaccine for intramuscular injection

Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml

OTHER

Placebo comparator (without active ingredient) for intramuscular injection

Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml

Trial Locations (5)

108819

FSBSI Chumakov FSC R&D IBP RAS, Moscow

196143

Eco-Safety Scientific Research Center LLC, Saint Petersburg

610027

Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia, Kirov

620043

Center for Family Medicine Joint Stock Company (CSM JSC), Yekaterinburg

630559

FGBUZ MSCh No. 163 FMBA of Russia, Novosibirsk

All Listed Sponsors
lead

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

OTHER_GOV

NCT05046548 - This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 | Biotech Hunter | Biotech Hunter