A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Completed · Phase 2 · NCT06097299
Conditions: Respiratory Syncytial Virus
At a glance
- Research payments reported, 2025
- $795,479
- U.S. investigators named
- 43
- Sites paid
- 25
- Planned or actual enrollment
- 349
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- mRNA-1345 (biological), Placebo (biological)
- Dates
- Started 2023-10-24; completion 2025-06-27
- Results posted
- Yes
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to \<5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to \<18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3). Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.
From ClinicalTrials.gov, last updated 2026-08-18. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $795,479 in research payments for this study in 2025 (479 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
- Tequilla L. Pryor, M.D. Pediatrics · Fpo, AP
- Matthew J. Douglas, M.D. Emergency Medicine · Phoenix, AZ
- Carlos J. Lopez, M.D. Family Medicine · Phoenix, AZ
- Kevin Oei Family Medicine · Downey, CA
- Apinya B. Vutikullird, D.O. Family Medicine · Cypress, CA
- Adalberto Aguilera, MD General Practice · Orlando, FL
- Anneyd M. Avalos Pena, MD Internal Medicine · Doral, FL
- Salma H. Elfaki, MD Pediatrics · Orlando, FL
- Helena M. Gaviria, MD Pediatrics · Tamarac, FL
- Randall E. Reese, MD Pediatrics · Gulf Breeze, FL
- Bhumi M. Upadhyay, M.D. Pediatrics · Tampa, FL
- Yael R. Elfassy, M.D. Pediatrics · Savannah, GA
- Lance E. Slade, M.D. Pediatrics · Macon, GA
- Jeffrey B. Baker, M.D. Family Medicine · Idaho Falls, ID
- Mark A. Turner, MD Family Medicine · Meridian, ID
- Michael A. Rausch, M.D. Family Medicine · Augusta, KS
- Derrick R. Ward, M.D. Allergy & Immunology · Overland Park, KS
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Scott P. Striplin, M.D. OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Dinesh Nayak, MD Pediatrics · Southgate, MI
- Gary D. Berman, M.D. Allergy & Immunology · Minneapolis, MN
- Paul G. Matherne, MD Family Medicine · Gulfport, MS
- Sara S. Friedman, M.D. OB-GYN (Obstetrics & Gynecology) · Albuquerque, NM
- Frank Eder, MD Family Medicine · Binghamton, NY
- Jennifer Nayak, MD Pediatric Infectious Disease · Rochester, NY
- Jeffrey S. Gerber, M.D., PH.D. Pediatric Infectious Disease · Philadelphia, PA
- Kem Yenal, MD Family Medicine · Phila, PA
- Gamalier Mestre, MD General Practice · Fajardo, PR
- Richard K. Ohnmacht, MD Pediatrics · Cranston, RI
- Robert A. Clifford, M.D. Pediatrics · Charleston, SC
- Carole I. Mercer, M.D. Adolescent Medicine · Simpsonville, SC
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- John W. Clinton III, M.D. Pediatrics · Port Lavaca, TX
- Oscar L. De Valle, M.D. Family Medicine · Houston, TX
- Malini Hebbur, M.D. Pediatrics · Plano, TX
- Faith L. Holmes, M.D. Family Medicine · Austin, TX
- Benjamin A. Marcum, M.D. Family Medicine · Stephenville, TX
- Roozbeh Sharif, M.D., M.ED., M.SC. Pulmonology · Nederland, TX
- Clifford W. Yut, MD Pediatrics · The Woodlands, TX
- Judith L. Kirstein, M.D. Family Medicine · West Jordan, UT
- John L. Richards, MD Family Medicine · South Jordan, UT
- Richard L. Bennett JR., MD Pediatrics · Richmond, VA
- John K. Scott, MD Family Medicine · Glen Allen, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research Inc $155,452
- West Houston Clinical Research Service $90,933
- Elias Research Associates LLC $88,819
- Dynamed Clinical Research LP $70,131
- Clinical Research Prime Idaho Falls LLC $60,201
- Strong Memorial Hospital, NY $52,282
- Clinical Research PArtners LLC $37,281
- Dynamed Philadelphia LLC $31,001
- Enso Mb LLC D B A Victoria Clinical Research Group $27,220
- $24,176
- Javara Inc $23,285
- Elligo Health Research Inc $17,251
- Children's Hospital of Philadelphia, PA $14,983
- University Clinical Research Deland LLC $13,973
- Acrc Trials $11,822
- Clinical Research Institute Inc $11,013
- Med Care Research Corp $10,784
- Rex Clinical Trials LLC $10,100
- Tribe Clinical Research LLC $7,830
- Sec Clinical Research LLC $6,848
- Sandhill Research LLC $6,750
- Cenexel Iresearch LLC $6,230
- Alliance for Multispecialty Research LLC $5,670
- Coastalpediatricresearch $4,050
- Headlands Horizons LLC $3,894
- Ark Clinical Research LLC $3,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.