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 · NCT06060457
Conditions: Respiratory Syncytial Virus
At a glance
- Research payments reported, 2025
- $396,330
- U.S. investigators named
- 14
- Sites paid
- 13
- Planned or actual enrollment
- 1,900
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- Placebo (biological), mRNA-1345 (biological), Fluzone HD (biological)
- Dates
- Started 2023-09-25; completion 2024-06-07
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2025-07-30. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $396,330 in research payments for this study in 2025 (93 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jack B. Vu, MD Family Medicine · Lake Forest, CA
- Jorge T. Caso, MD Family Medicine · Miami, FL
- Arnaldo Orellana Molina, MD General Practice · Tampa, FL
- Carlos A. Sesin, M.D. Rheumatology · Miami Beach, FL
- Ronald Z. Surowitz, D.O. Family Medicine · Jupiter, FL
- Jon P. Finley, M.D. Sports Medicine · Stockbridge, GA
- Basmah A. Jalil, MD Rheumatology · Bethesda, MD
- Sean C. Kerby, M.D. Family Medicine · Gulfport, MS
- Sridhar Guduri, M.D Allergy & Immunology · Dublin, OH
- Melita L. Tate, MD Internal Medicine · Tulsa, OK
- David S. Wheeler, MD Pulmonology · Philadelphia, PA
- Charles M. Fogarty, MD Pulmonology · Spartanburg, SC
- Muhammad Irfan, M.D. Internal Medicine · Tomball, TX
- Ronald M. Pucillo, M.D. Family Medicine · Sugar Land, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Spartanburg Medical Research LLC $111,863
- Health Awareness LLC $71,373
- Javara Inc $60,017
- Delricht Research $45,479
- Cra Headlands LLC $26,644
- Sweet Hope Research Speciality Inc $21,765
- Dm Boston LLC $18,834
- Suncoast Research Associates LLC DBA Sra Trials $18,640
- New Tampa Health Inc $10,750
- Dynamed Clinical Research LP $4,576
- Artemis Headlands LLC $4,221
- Dynamed Philadelphia LLC $1,850
- Cr Services Acquisition US LLC $319
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.