Trials / Completed
CompletedNCT04515147
A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 668 (actual)
- Sponsor
- CureVac · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.
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 6 μg | Participants will receive an intramuscular injection by needle in the deltoid area. |
| BIOLOGICAL | CVnCoV 12 μg | Participants will receive an intramuscular injection by needle in the deltoid area. |
| BIOLOGICAL | Hepatitis A vaccine | Participants will receive an intramuscular injection by needle in the deltoid area. |
| BIOLOGICAL | Pneumococcal vaccine | Participants will receive an intramuscular injection by needle in the deltoid area. |
| BIOLOGICAL | CVnCoV 12μg | Participants will receive an intramuscular injection by needle in the deltoid area. |
Timeline
- Start date
- 2020-09-21
- Primary completion
- 2022-02-21
- Completion
- 2022-02-21
- First posted
- 2020-08-17
- Last updated
- 2023-09-28
- Results posted
- 2023-09-28
Locations
2 sites across 2 countries: Panama, Peru
Source: ClinicalTrials.gov record NCT04515147. Inclusion in this directory is not an endorsement.