Trials / Unknown
UnknownNCT05726084
Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older
Multicentre, Double-blind, Randomized, Prospective, Placebo-controlled Trial to Assess the Immunogenicity, Efficacy and Safety of the Coronavirus Vaccine in Healthy Volunteers Aged 18 Years and Older
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 16,304 (estimated)
- Sponsor
- St. Petersburg Research Institute of Vaccines and Sera · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The trial will be conducted in two stages (Stage IIb and Stage III). • Stage IIb Participants will be vaccinated one dose or two doses of the Convacell vaccine. Investigators will compare one dose and two doses groups and will choose the best vaccine dosage regimen in terms of immunogenicity and safety. • Stage III Participants will be vaccinated the Convacell vaccine or Placebo. Investigators will use the dosage regimen chosen in IIb stage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-10-24
- Primary completion
- 2023-10-30
- Completion
- 2023-12-30
- First posted
- 2023-02-13
- Last updated
- 2023-08-30
Locations
6 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05726084. Inclusion in this directory is not an endorsement.