Trials / Active Not Recruiting
Active Not RecruitingNCT06067230
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,153 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to \<60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1345 | Sterile liquid for injection |
Timeline
- Start date
- 2023-10-06
- Primary completion
- 2026-07-30
- Completion
- 2026-07-30
- First posted
- 2023-10-04
- Last updated
- 2025-08-08
Locations
44 sites across 4 countries: United States, Canada, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06067230. Inclusion in this directory is not an endorsement.