Trials / Completed
CompletedNCT05572658
Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
mRNA-1345-P901 Study: RSV Outcomes Study Extension
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,994 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
Summary
The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.
Detailed description
This study will evaluate real-world data (RWD) and data from eligible United States (US) based participants from Study mRNA-1345-P301 (NCT05127434) for additional health and economic outcomes such as hospitalizations, healthcare resource utilization, disease exacerbations, and costs, associated with usage of the mRNA-1345 vaccine. The results from the current study (mRNA-1345-P901) are intended to complement the results from the mRNA-1345-P301 study. No interventions will be administered during the current study (mRNA-1345-P901).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | mRNA-1345 | Sterile liquid for injection |
| BIOLOGICAL | Placebo | 0.9% sodium chloride (normal saline) injection |
Timeline
- Start date
- 2022-09-15
- Primary completion
- 2023-09-30
- Completion
- 2023-09-30
- First posted
- 2022-10-10
- Last updated
- 2025-01-24
Locations
109 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05572658. Inclusion in this directory is not an endorsement.