Trials / Completed
CompletedNCT05105048
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1647 | Lyophilized product that is reconstituted with saline |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2021-11-08
- Primary completion
- 2023-08-10
- Completion
- 2023-08-10
- First posted
- 2021-11-03
- Last updated
- 2023-09-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05105048. Inclusion in this directory is not an endorsement.