Trials / Completed
CompletedNCT05252338
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVSQIV in Healthy Adults
A Phase 1, Open-label, Dose-escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational Seasonal Quadrivalent Influenza mRNA Vaccine CVSQIV Administered Intramuscularly in Healthy Younger and Older Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- CureVac · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels.
Detailed description
This is a Phase 1, open-label, dose-escalation FIH trial to evaluate the safety, reactogenicity and immunogenicity of different dose levels of CVSQIV using an adaptive dose-finding design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVSQIV | Participants will receive an intramuscular injection by needle in the deltoid area. |
Timeline
- Start date
- 2022-02-07
- Primary completion
- 2022-09-27
- Completion
- 2022-09-27
- First posted
- 2022-02-23
- Last updated
- 2023-06-06
Locations
3 sites across 1 country: Panama
Source: ClinicalTrials.gov record NCT05252338. Inclusion in this directory is not an endorsement.