Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Convacell Vaccine Phase 2b/3 Trial
NCT05726084Phase 3
Key facts
- Status
- Unknown
- Start
- Oct 2022
- Primary completion
- Oct 2023
- Countries
- 1
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Convacell
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of Convacell in coronavirus disease 2019 (COVID-19) (4 arms), sponsored by Saint Petersburg Scientific Research Institute of Vaccines and Serums. Primary endpoints: Change in titer of IgG antibodies to N-protein of SARS-CoV-2 and Frequency of symptomatic COVID-19 with laboratory-confirmed infection at 6 months. Status: unknown.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Convacell 1 Dose (Stage IIb)
Single intramuscular dose of Convacell
Convacell 2 Doses (Stage IIb)
Two intramuscular doses of Convacell
Convacell Chosen Regimen (Stage III)
Chosen regimen (1 dose) of Convacell
Placebo (Stage III)
Placebo injection
03
Who it enrols
Healthy volunteers aged 18 and older with no history of COVID-19 or vaccination in the last 6 months, and no significant chronic or acute diseases.
04
Endpoints
Primary
Change in titer of IgG antibodies to N-protein of SARS-CoV-2
Frequency of symptomatic COVID-19 with laboratory-confirmed infection
Secondary
Change in titer of IgM antibodies to N-protein of SARS-CoV-2
Proportion of SARS-CoV-2 seropositive participants
Frequency of seroconversion (appearance of specific antibodies to SARS-CoV-2 N-protein)
Change from Baseline in the Mean Specifically Sensitized T-lymphocytes
Number of volunteers hospitalized with COVID-19
Frequency of laboratory confirmed asymptomatic SARS-CoV-2 infections
Frequency of laboratory-confirmed severe COVID-19
Overall frequency of all AEs/SAEs
Beyond the preview
Go deeper on NCT05726084.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05726084.