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 · NCT05127434
Conditions: Respiratory Syncytial Virus
At a glance
- Research payments reported, 2025
- $22.5M
- U.S. investigators named
- 117
- Sites paid
- 68
- Planned or actual enrollment
- 36,814
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- Placebo (drug), mRNA-1345 (drug)
- Dates
- Started 2021-11-17; completion 2025-07-28
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-09-29. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $22.5M in research payments for this study in 2025 (1,547 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
- William A. Nixon, MD Family Medicine · Guntersville, AL
- Hayes Williams, M.D., PHD Internal Medicine · Vestavia, AL
- Priyantha N. Wijewardane, M.D. Internal Medicine · Little Rock, AR
- Abram H. Burgher, MD Pain Medicine · Phoenix, AZ
- Joseph D. Davis, M.D. Gastroenterology · Chandler, AZ
- Matthew W. Doust, MD Pain Medicine · Scottsdale, AZ
- Robert E. Mutterperl, DO Internal Medicine · Tucson, AZ
- Gerald R. Shockey, M.D. Family Medicine · Mesa, AZ
- Hessam Aazami, M.D. General Practice · Canoga Park, CA
- Gary K. Boone, M.D. Family Medicine · San Diego, CA
- Don F. De Francisco, M.D. Psychiatry · Newport Beach, CA
- Augusto E. Focil, M.D.,M.P.H.,CCD Family Medicine · Oxnard, CA
- Rafael Lupercio, M.D. Critical Care Medicine · Redding, CA
- Jeffrey S. Overcash, MD Emergency Medicine · Chula Vista, CA
- Mallu C. Reddy, MD Internal Medicine · Pomona, CA
- David A. Rosenberg, M.D. Neurology · Los Alamitos, CA
- Robert J. Semo, MD OB-GYN (Obstetrics & Gynecology) · San Diego, CA
- Michael P. Waters, MD Emergency Medicine · Chula Vista, CA
- Timothy D. Colander, MD Family Medicine · Aurora, CO
- Stanton R. Elzi, MD Internal Medicine · Wheat Ridge, CO
- Clint Flanagan, MD Family Medicine · Dacono, CO
- Michael S. Thakor, MD Rheumatology · Fort Collins, CO
- Susann Varano I, MD Geriatric Medicine · New Haven, CT
- Jose Bordon, MD Infectious Disease · Washington, DC
- Mira Baron, MD, CPI Internal Medicine · West Palm Beach, FL
- Margaret Chang, MD Family Medicine · Edgewater, FL
- Jose L. Diaz, MD Pulmonology · Leesburg, FL
- Eva-maria Heurich, D.O. Family Medicine · Orlando, FL
- Gilberto Jimenez, MD Internal Medicine · Hialeah, FL
- Michael J. Koren, M.D. Cardiology · Gainesville, FL
- Michael A. Stephens, MD Family Medicine · Orange Park, FL
- Guy S. Strauss, D.O. Internal Medicine · Lake City, FL
- Ronald Z. Surowitz, D.O. Family Medicine · Jupiter, FL
- Julio C. Vijil JR., MD, MPH Nephrology (Kidney) · Plantation, FL
- Debra Weinstein, MD Internal Medicine · Boynton Beach, FL
- Paul S. Bradley, MD Internal Medicine · Savannah, GA
- Jon P. Finley, M.D. Sports Medicine · Stockbridge, GA
- Charlotte E. Grayson- Mathis, M.D. Internal Medicine · Fayetteville, GA
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Gretchen K. Mitchell, MD OB-GYN (Obstetrics & Gynecology) · Cumming, GA
- Joseph G. Surber, DO Family Medicine · Columbus, GA
- Marvin D. Tark, MD Pain Medicine · Marietta, GA
- David Fitz-patrick, M.D. Specialist · Honolulu, HI
- Mark A. Turner, MD Family Medicine · Meridian, ID
- Mary Brown, MD Internal Medicine · Rockford, IL
- Manohar L. Jethani, MD Family Medicine · Berwyn, IL
- Robert J. Buynak, M.D. Internal Medicine · Valparaiso, IN
- Carlos A. Fierro, MD General Practice · Kansas City, KS
- Brian A. Smith, MD Family Medicine · Versailles, KY
- Sherri B. Casey, MD Pediatrics · Covington, LA
- Michael Cotugno Emergency Medicine · New Iberia, LA
- Patrick M. Dennis, MD Emergency Medicine · New Orleans, LA
- Clint C. Guillory, MD Family Medicine · Monroe, LA
- Katherine F. Pearce, M.D. Internal Medicine · Baton Rouge, LA
- Elia E. Acevedo Diaz, M.D Psychiatry · Gaithersburg, MD
- Richard A. Bernstein, M.D. Pulmonology · Annapolis, MD
- Shishir K. Khetan, MD Internal Medicine · Rockville, MD
- Rebecca A. Rivard, D.O. Family Medicine · Roseville, MI
- Derrick Williamson, DO Family Medicine · Southfield, MI
- Gary D. Berman, M.D. Allergy & Immunology · Minneapolis, MN
- Merlin B. Fausett, M.D. Maternal-Fetal Medicine (High-Risk Pregnancy) · Missoula, MT
- Nitinchandra D. Desai, MD Internal Medicine · Fayetteville, NC
- Barton G. Williams, MD Family Medicine · Wilmington, NC
- Adam B. Brosz, M.D. Family Medicine · Grand Island, NE
- Tamara A. Doehner, M.D. Hospitalist · Omaha, NE
- David J. Ensz, M.D. Family Medicine · South Sioux City, NE
- William P. Fitzgibbons, M.D. Family Medicine · Elkhorn, NE
- Jay R. Meyer, MD Emergency Medicine · Lincoln, NE
- Frederick C. Raiser III, DO Emergency Medicine · Omaha, NE
- Thomas A. Wolf, MD Family Medicine · Fremont, NE
- Gaurang R. Brahmbhatt, M.D. Family Medicine · Hoboken, NJ
- Duane C. Anderson, MD OB-GYN (Obstetrics & Gynecology) · Las Vegas, NV
- Raj P. Singh, M.D. Nephrology (Kidney) · Las Vegas, NV
- Robert C. Cupelo, M.D. Internal Medicine · East Syracuse, NY
- Matthew G. Davis, MD Family Medicine · Rochester, NY
- Michael Gerdis, MD Gastroenterology · Yonkers, NY
- Suchet R. Patel, MD Family Medicine · Endwell, NY
- Seref Bornovali, MD Internal Medicine · Loveland, OH
- Michael B. Butcher, M.D. Family Medicine · Cincinnati, OH
- Antoinette A. Pragalos, M.D. Internal Medicine · Cincinnati, OH
- Richard A. Lowrance III, MD Family Medicine · Mustang, OK
- Kyle W. Rickner, M.D Family Medicine · Edmond, OK
- Beal Essink, MD Psychiatry · Salem, OR
- Harris B. Cohen, M.D. Family Medicine · Horsham, PA
- Kem Yenal, MD Family Medicine · Phila, PA
- Carmen Colon-tarbal, M.D. Pediatrics · San Juan, PR
- Jesus W. Rodriguez Rodriguez, M.D. General Practice · Ponce, PR
- Jorge L. Santana - Bagur, M.D. Infectious Disease · Manati, PR
- Amy M. Sprague, M.D. Nephrology (Kidney) · Georgetown, SC
- Jeffrey A. Henderson, M.D., M.P.H. Internal Medicine · Rapid City, SD
- Madhavi Ampajwala, M.D Family Medicine · Frisco, TX
- Matthew A. Brimberry, M.D. Family Medicine · Austin, TX
- Bonnie E. Colville, D.O. Family Medicine · Houston, TX
- Oscar L. De Valle, M.D. Family Medicine · Houston, TX
- Douglas S. Denham, D.O. Family Medicine · San Antonio, TX
- Gregory M. Fuller, M.D. Family Medicine · North Richland Hills, TX
- James M. Harvey, MD Family Medicine · Fort Worth, TX
- Lisa R. Holloway, D.O. Family Medicine · Houston, TX
- Tiffany T. Huynh, OD Optometrists · Houston, TX
- Benjamin A. Marcum, M.D. Family Medicine · Stephenville, TX
- Saumil A. Mehta, MD Internal Medicine · Plano, TX
- Vicki E. Miller, M.D. Family Medicine · Pasadena, TX
- Paul K. Pickrell, MD Rheumatology · Austin, TX
- Fredric A. Santiago, M.D. Internal Medicine · Beaumont, TX
- Jeffrey G. Stewart, M.D. Family Medicine · Carrollton, TX
- Harish N. Thakkar, M.D. Internal Medicine · Sugar Land, TX
- Eduardo Uribe, M.D. Family Medicine · San Benito, TX
- John M. Hemmersmeier, MD Family Medicine · Ogden, UT
- Judith L. Kirstein, M.D. Family Medicine · West Jordan, UT
- Justin W. Mansfield, M.D. Internal Medicine · Ogden, UT
- Bryce K. Peterson, MD Family Medicine · Bountiful, UT
- Jared B. Probst, MD Family Medicine · Salt Lake City, UT
- George H. Freeman, M.D. Research Study Specialist · Newport News, VA
- Banu P. Myneni, D.O. Family Medicine · Portsmouth, VA
- Ashley E. Fuller, MD OB-GYN (Obstetrics & Gynecology) · Seattle, WA
- Sheryl M. Marks, MD Anesthesiology · Renton, WA
- Richard L. Sellman JR., M.D. Critical Care Medicine · La Crosse, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Qcare Site Services Inc $2.7M
- Elligo Health Research Inc $1.8M
- Dynamed Clinical Research LP $1.3M
- Velocity Clinical Research Inc $1.2M
- Qcare Site Services $1.1M
- Pharmaseek LLC $984,197
- Baptist Health Center for Clinical Research $862,141
- Jacksonville Center for Clinical Research $692,512
- Paradigm Clinical Rsrch Center Inc $557,108
- Wr Pri LLC $532,369
- Johnson County Clin-Trials $483,015
- Rochester Clinical Research Inc $473,029
- Wr Msra LLC $471,470
- Marwah Investments Corporation $400,460
- Tucson Neuroscience Research LLC $398,847
- Wr Mount Vernon Clinical Research LLC $353,033
- Hope Research Institute LLC $348,067
- National Institute of Clinical Research $343,778
- West Houston Clinical Research $332,529
- Aim Trials LLC $329,222
- Texas Center for Drug Development $312,151
- Dynamed Detroit LLC $293,862
- Drug Trials America Inc $293,514
- Helios Cr Inc $273,124
- Clinical Site PArtners $272,321
- B&b Medical Inc $265,300
- Javara Inc $253,580
- Trial Management Associates LLC $234,733
- Clinical Site PArtners LLC $215,152
- Delricht LLC $203,652
- Wr Mccr LLC $196,113
- Dynamed Chicago LLC $191,629
- Brcr Medical Center Inc $181,483
- Drug Studies America $179,887
- Cbh Health LLC $171,285
- Seattle Crc LLC $168,000
- Summit Headlands LLC $167,343
- Achieve Clinical Research LLC $164,875
- Rainer Crc LLC DBA Rainer Clin $163,824
- Sandhill Research LLC $163,676
- Rainer Crc LLC $162,176
- Dynamed Philadelphia LLC $146,616
- David Fitz-Patrick MD. Inc $146,036
- Clinical Research Institute Inc $142,205
- Science 37 Inc $134,838
- Cra Headlands LLC $132,877
- Fomat Medical Research Inc $129,572
- Empirican Prn Inc $128,202
- Montana Medical Research Inc $118,082
- Panamerican Clinical Research $108,220
- Tekton Research LLC $105,092
- Cenexel Iresearch LLC $103,747
- Caribbean Medical Research Center $102,500
- Carolina Ins for Clin Research LLC $99,276
- Lsb Research Group LLC $97,581
- Clinical Trials of Texas Inc. $91,587
- Clinical Research Consulting LLC $85,506
- Cr Services Acquisition US LLC $82,080
- Boeson Research LLC $71,971
- Cra Headlands LLC DBA Clinical $66,353
- Alliance for Multispecialty Research LLC $64,694
- Black Hills Center for America $59,144
- Lynn Health Science Institute $58,059
- Great Lakes Research Institute $51,943
- Community Research Management $39,991
- Health Research of Hampton Road Inc $33,721
- Recinto De Ciencias Medicas $23,672
- Dm Clinical Research - Bellaire $2,754
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.