A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
Completed · Phase 3 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Key facts
- Study ID
- NCT05330975
- Run by
- ModernaTX, Inc.
- People needed
- 3317
- Starts
- 2022-04-01
- Expected to finish
- 2024-11-08
- Last updated by the study team
- 2025-12-30
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Del Sol Research Management - Clinedge - PPDS — Tucson, Arizona, United States
- Paragon Rx Clinical, Inc — Garden Grove, California, United States
- Ark Clinical Research — Long Beach, California, United States
- Long Beach Clinical Trials, LLC (Site 1) — Long Beach, California, United States
- Long Beach Clinical Trials, LLC (Site 2) — Long Beach, California, United States
- Central Valley Research, LLC — Modesto, California, United States
- Velocity Clinical Research - Panorama City — Panorama City, California, United States
- Empire Clinical Research — Pomona, California, United States
- Acclaim Clinical Research — San Diego, California, United States
- Medical Center For Clinical Research - M3 WR - ERN - PPDS — San Diego, California, United States
- Ark Clinical Research — Tustin, California, United States
- Chase Medical Research LLC — Waterbury, Connecticut, United States
- Teradan Clinical Trials — Brandon, Florida, United States
- Revival Research Corporation - Clinedge - PPDS — Doral, Florida, United States
- Dolphin Medical Research — Doral, Florida, United States
- Indago Research and Health Center — Hialeah, Florida, United States
- Westside Center for Clinical Research - ERN - PPDS — Jacksonville, Florida, United States
- Suncoast Research Group LLC - ERN-PPDS — Miami, Florida, United States
- Suncoast Research Associates LLC - ERN - PPDS — Miami, Florida, United States
- Floridian Clinical Research - ClinEdge - PPDS — Miami Lakes, Florida, United States
- Tekton Research - Georgia - Platinum - PPDS — Chamblee, Georgia, United States
- Lifeline Primary Care / CCT Research — Lilburn, Georgia, United States
- Georgia Clinic / CCT Research — Norcross, Georgia, United States
- Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS — Savannah, Georgia, United States
- Central Research Associates Inc — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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