A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
Completed · Phase 1 · NCT04528719
Conditions: Respiratory Syncytial Virus
At a glance
- Research payments reported, 2025
- $614,483
- U.S. investigators named
- 24
- Sites paid
- 16
- Planned or actual enrollment
- 651
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- mRNA-1345 (biological), Placebo (drug)
- Dates
- Started 2020-09-30; completion 2024-07-18
- Results posted
- Not yet
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
From ClinicalTrials.gov, last updated 2024-08-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $614,483 in research payments for this study in 2025 (166 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
- Gary K. Boone, M.D. Family Medicine · San Diego, CA
- Ashraf A. Affan, MD Pediatrics · Jacksonville, FL
- Mira Baron, MD, CPI Internal Medicine · West Palm Beach, FL
- Salma H. Elfaki, MD Pediatrics · Orlando, FL
- Paul S. Bradley, MD Internal Medicine · Savannah, GA
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Joseph G. Surber, DO Family Medicine · Columbus, GA
- David Fitz-patrick, M.D. Specialist · Honolulu, HI
- Martha S. Fanning, M.D. Emergency Medicine · Overland Park, KS
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Scott P. Striplin, M.D. OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Adam B. Brosz, M.D. Family Medicine · Grand Island, NE
- David J. Ensz, M.D. Family Medicine · South Sioux City, NE
- Charles Harper JR., MD Internal Medicine · Norfolk, NE
- Daniel J. Leonard IV, D.O. Pediatrics · Hastings, NE
- Quito O. Carr, M.D. Family Medicine · Albuquerque, NM
- Frank Eder, MD Family Medicine · Binghamton, NY
- Luis De La Cruz, MD Sleep Medicine · Spartanburg, SC
- Gregory J. Feldman, MD Pulmonology · Columbia, SC
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- Douglas S. Denham, D.O. Family Medicine · San Antonio, TX
- Vicki E. Miller, M.D. Family Medicine · Pasadena, TX
- Marc O. Anderson, MD Family Medicine · Layton, UT
- Richard L. Bennett JR., MD Pediatrics · Richmond, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Alliance for Multispecialty Research LLC $158,248
- Velocity Clinical Research Inc $75,509
- B&b Medical Inc $62,843
- Tanner Clinic $60,184
- Cenexel Iresearch LLC $53,270
- Meridian Clinical Research LLC $47,826
- Dynamed Clinical Research LP $43,334
- Clinical Trials of Texas Inc. $34,101
- Medpharmics LLC $19,169
- Keystone Research LLC $18,200
- David Fitz-Patrick MD. Inc $13,385
- University Clinical Research Deland LLC $10,148
- Paradigm Clinical Rsrch Center Inc $9,159
- Clinical Research PArtners $6,126
- Clinical Trials of Texas Inc $2,131
- Institute for The Advancement $850
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.