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 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
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.
Key facts
- Study ID
- NCT04528719
- Run by
- ModernaTX, Inc.
- People needed
- 651
- Starts
- 2020-09-30
- Expected to finish
- 2024-07-18
- Last updated by the study team
- 2024-08-07
Who can join
Age: 1 and older, up to 79. Sex: any. Healthy volunteers: accepted.
Where it is running
- Paradigm Clinical Research Institute Inc - ClinEdge - PPDS — La Mesa, California, United States
- Mills Clinical Research — West Hollywood, California, United States
- Accel Research Site - Angel Kids Pediatrics - ERN - PPDS — DeLand, Florida, United States
- Accel Research Sites - Nona Pediatric Center - ERN - PPDS — Orlando, Florida, United States
- Palm Beach Research - ClinEdge - PPDS — West Palm Beach, Florida, United States
- Centricity Research - Roswell - HyperCore - PPDS — Columbus, Georgia, United States
- IResearch Atlanta LLC — Decatur, Georgia, United States
- Velocity Clinical Research (Savannah - Georgia) - PPDS — Savannah, Georgia, United States
- East-West Medical Research Institute — Honolulu, Hawaii, United States
- Synexus - Optimal Research - Peoria — Peoria, Illinois, United States
- Velocity Clinical Research (Sioux City - Iowa) - PPDS — Sioux City, Iowa, United States
- Michael W. Simon, M.D., PSC — Nicholasville, Kentucky, United States
- Velocity Clinical Research (Lafayette - Louisiana) - PPDS — Lafayette, Louisiana, United States
- Velocity Clinical Research (Metaire - Louisiana) - PPDS — Metairie, Louisiana, United States
- Velocity Clinical Research (Slidell - Louisiana) - PPDS — Slidell, Louisiana, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Alliance for Multispecialty Research - Kansas City — Kansas City, Missouri, United States
- Velocity Clinical Research (Grand Island - Nebraska) - PPDS — Grand Island, Nebraska, United States
- Velocity Clinical Research (Hastings - Nebraska) - PPDS — Hastings, Nebraska, United States
- Velocity Clinical Research (Norfolk - Nebraska) - PPDS — Norfolk, Nebraska, United States
- Velocity Clinical Research (Omaha - Nebraska) - PPDS — Omaha, Nebraska, United States
- Velocity Clinical Research (Albuquerque - New Mexico) - PPDS — Albuquerque, New Mexico, United States
- Velocity Clinical Research (Binghamton - New York) - PPDS — Binghamton, New York, United States
- Velocity Clinical Research - Medford - ERN - PPDS — Medford, Oregon, United States
- Velocity Clinical Research - Columbia - PPDS — Columbia, South Carolina, United States
Full record on ClinicalTrials.gov
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