Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT05572658
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2022-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
Sponsor:
ModernaTX, Inc.
Organization:
Study Overview
Official Title:
mRNA-1345-P901 Study: RSV Outcomes Study Extension
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSE
Brief 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).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: