A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
Completed · Phase 3 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.
Key facts
- Study ID
- NCT06060457
- Run by
- ModernaTX, Inc.
- People needed
- 1900
- Starts
- 2023-09-25
- Expected to finish
- 2024-06-07
- Last updated by the study team
- 2025-07-30
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Scottsdale Clinical Trials — Scottsdale, Arizona, United States
- Headlands Research, Inc. — Scottsdale, Arizona, United States
- West Coast Research LLC — Dublin, California, United States
- Artemis Institute for Clinical Research — Riverside, California, United States
- Peninsula Research Associates (PRA) — Rolling Hills Estates, California, United States
- Acclaim Clinical Research — San Diego, California, United States
- Neoclinical Research — Hialeah, Florida, United States
- Health Awareness INC — Jupiter, Florida, United States
- South Florida Research Center, Inc. — Miami, Florida, United States
- Suncoast Research Associates, LLC — Miami, Florida, United States
- Headlands Research - Orlando — Orlando, Florida, United States
- New Tampa Health, Inc — Tampa, Florida, United States
- Clinical Research Atlanta/Headlands — Stockbridge, Georgia, United States
- Bingham Memorial Hospital — Blackfoot, Idaho, United States
- DM Clinical Research- River Forest — River Forest, Illinois, United States
- Velocity Clinical Research-Baton Rouge — Baton Rouge, Louisiana, United States
- DelRicht Research @ Neighborhood Health — Prairieville, Louisiana, United States
- DM Clinical Research - Brookline — Brookline, Massachusetts, United States
- DM Clinical Research - Southfield — Southfield, Michigan, United States
- Delricht Research at Gulfport Memorial — Gulfport, Mississippi, United States
- Delricht Research — Springfield, Missouri, United States
- Be Well Clinical Studies, LLC — Lincoln, Nebraska, United States
- Velocity Clinical Research-Norfolk — Norfolk, Nebraska, United States
- Trial Management Associates, LLC — Wilmington, North Carolina, United States
- Synexus AES - Akron — Akron, Ohio, United States
Full record on ClinicalTrials.gov
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