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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

NCT05046548 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-11-12

No results posted yet for this study

Summary

Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.

Conditions

  • Coronavirus Infections
  • Vaccine

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

Sponsors & Collaborators

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

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-03
Primary Completion
2020-10-15
Completion
2021-10-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046548 on ClinicalTrials.gov