Trials / Terminated
TerminatedNCT04498247
A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)
A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.
Detailed description
This study was terminated and modifications to the dosing regimens and clinical/laboratory procedures were implemented for trial discontinuation according to Protocol Amendment 04. Per protocol, certain panels were never enrolled and/or the second dose of study intervention was not administered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V591 | 1 or 2 ascending doses of V591 will be administered via intramuscular (IM) injection. |
| OTHER | Placebo | Placebo (0.9% sodium chloride) administered via IM injection. |
Timeline
- Start date
- 2020-08-27
- Primary completion
- 2021-03-05
- Completion
- 2021-03-05
- First posted
- 2020-08-04
- Last updated
- 2021-12-23
- Results posted
- 2021-12-23
Locations
9 sites across 3 countries: United States, Austria, Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04498247. Inclusion in this directory is not an endorsement.