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Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older

NCT05726084 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 16304

Last updated 2023-08-30

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are:

* To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell vaccine;
* To assess the epidemiological effectiveness of the Convacell vaccine in the prevention of SARS-CoV-2 infection and development of severe COVID-19 compared with placebo when single or double intramuscular injection.

Conditions

  • COVID-19
  • Coronavirus Infections
  • Respiratory Tract Infections
  • COVID-19 Respiratory Infection

Interventions

BIOLOGICAL

Subunit recombinant vaccine for the prevention of coronavirus infection

solution for intramuscular injection, 0.5 ml

BIOLOGICAL

Placebo

solution for intramuscular injection, 0.5 ml

Sponsors & Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera

    lead OTHER_GOV

Principal Investigators

  • Ellina Ruzanova · St. Petersburg Research Institute of Vaccines and Sera

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2023-10-30
Completion
2023-12-30

Countries

  • Russia

Study Locations

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Drugs
Diseases

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 NCT05726084 on ClinicalTrials.gov