Trials / Completed
CompletedNCT04652102
A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 39,680 (actual)
- Sponsor
- CureVac · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVnCoV | Intramuscular (IM) injection. |
| BIOLOGICAL | Placebo | Intramuscular (IM) injection. |
| BIOLOGICAL | Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program | Intramuscular (IM) injection will be received as standard of care (SoC) outside the study. |
Timeline
- Start date
- 2020-12-11
- Primary completion
- 2022-06-10
- Completion
- 2022-06-10
- First posted
- 2020-12-03
- Last updated
- 2024-04-29
- Results posted
- 2024-04-29
Locations
46 sites across 10 countries: Argentina, Belgium, Colombia, Dominican Republic, Germany, Mexico, Netherlands, Panama, Peru, Spain
Source: ClinicalTrials.gov record NCT04652102. Inclusion in this directory is not an endorsement.