A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Active, not recruiting · Phase 1 · NCT05743881
Conditions: Respiratory Syncytial Virus, Human Metapneumovirus
At a glance
- Research payments reported, 2025
- $345,919
- U.S. investigators named
- 18
- Sites paid
- 13
- Planned or actual enrollment
- 186
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- mRNA-1345 (biological), mRNA-1365 (biological), Placebo (biological), Nimenrix (drug)
- Dates
- Started 2023-02-15; completion 2029-08-31
- Results posted
- Not yet
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to \<24 months.
From ClinicalTrials.gov, last updated 2026-06-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $345,919 in research payments for this study in 2025 (287 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
- Peyman Banooni, M.D. OB-GYN (Obstetrics & Gynecology) · Beverly Hills, CA
- Kevin P. O'brien, M.D. Allergy & Immunology · Thornton, CO
- Mobeen H. Rathore, M.D. Pediatric Infectious Disease · Jacksonville, FL
- Erika L. Clayton, MD Emergency Medicine · Bolingbrook, IL
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Shane C. Mcallister, MD PHD Pediatric Infectious Disease · Minneapolis, MN
- Emmanuel B. Walter, M.D. Pediatrics · Durham, NC
- Daniel J. Leonard IV, D.O. Pediatrics · Hastings, NE
- David Fried, MD Internal Medicine · East Greenwich, RI
- Michael L. Leonardi, MD Pediatrics · Charleston, SC
- Clarence B. Creech II, MD Pediatric Infectious Disease · Nashville, TN
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- Michael E. Bornstein, MD Pediatrics · Richmond, TX
- Nalina Chandrasekharan, MD Pediatrics · Tomball, TX
- Malini Hebbur, M.D. Pediatrics · Plano, TX
- Martin Yudovich, MD Pediatrics · Houston, TX
- Sofia Teferi, MD Pediatrics · Richmond, VA
- Janet Englund Pediatric Infectious Disease · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research Inc $65,608
- Acrc Trials $45,691
- Neutra Life Sciences LLC $45,662
- Regents of the University of Minnesota $35,484
- Dynamed Clinical Research LP $28,462
- Matrix Clinical Research Inc $26,383
- Dynamed Chicago LLC $24,112
- Mercury Clinical Research Inc $21,192
- Palmetto Pediatrics PA $19,334
- Duke University $12,780
- University of Florida $11,024
- Seattle Children's Hospital, WA $8,628
- Vanderbilt University Medical Center, TN $1,560
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.