A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Key facts
- Study ID
- NCT05127434
- Run by
- ModernaTX, Inc.
- People needed
- 36814
- Starts
- 2021-11-17
- Expected to finish
- 2025-07-28
- Last updated by the study team
- 2025-08-19
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Accel Research Site - Achieve - Birmingham — Birmingham, Alabama, United States
- Lakeview Clinical Research — Guntersville, Alabama, United States
- AES - DRS - Optimal Research Alabama - Huntsville — Huntsville, Alabama, United States
- Hope Research Institute LLC - Hunt - PPDS — Hunt, Arizona, United States
- Hope Research Institute LLC - Hunt - PPDS — Hunt, Arizona, United States
- Desert Clinical Research, LLC - CCT — Mesa, Arizona, United States
- Hope Research Institute LLC - Phoenix - Hunt - PPDS — Phoenix, Arizona, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central — Phoenix, Arizona, United States
- Synexus Clinical Research US, Inc. - Phoenix Southeast — Phoenix, Arizona, United States
- Tucson Neuroscience Research - M3 WR — Tucson, Arizona, United States
- Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
- Velocity Clinical Research, Banning — Banning, California, United States
- Hope Clinical Research, LLC — Canoga Park, California, United States
- Velocity Clinical Research - Chula Vista - PPDS — Chula Vista, California, United States
- PPD Virtual - Science 37, Inc — Culver City, California, United States
- Velocity Clinical Research, San Diego — La Mesa, California, United States
- PRI, LLC - Los Alamitos - M3 WR — Los Alamitos, California, United States
- PRI, LLC - Newport Beach - M3 WR — Newport Beach, California, United States
- FOMAT Medical Research - FOMAT - HyperCore - PPDS — Oxnard, California, United States
- Reddy Care Medical — Pomona, California, United States
- Paradigm Clinical Research Institute Inc - ClinEdge - PPDS — Redding, California, United States
- Medical Center For Clinical Research - M3 WR — San Diego, California, United States
- Lynn Institute of Denver — Aurora, Colorado, United States
- Tekton Research - Fort Collins - PPDS — Fort Collins, Colorado, United States
- AES - DRS - Synexus Clinical Research US, Inc. - Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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