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A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Sponsor: ModernaTX, Inc.
Summary
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.
Official title: A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
Key Details
Gender
All
Age Range
5 Months - 24 Months
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2023-02-15
Completion Date
2029-08-31
Last Updated
2026-06-26
Healthy Volunteers
No
Interventions
mRNA-1345
Sterile liquid for injection
mRNA-1365
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) solution for injection
Nimenrix
Solution for injection
Locations (17)
Matrix Clinical Research
Los Angeles, California, United States
Meridian Clinical Research
Washington D.C., District of Columbia, United States
DM Clinical Research- River Forest
Melrose Park, Illinois, United States
MedPharmics - Platinum - PPDS
Lafayette, Louisiana, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Velocity Clinical Research - Providence
Providence, Rhode Island, United States
Palmetto Pediatrics, PA
North Charleston, South Carolina, United States
Vanderbilt Vaccine Research Program
Nashville, Tennessee, United States
CyFair
Houston, Texas, United States
Pediatric Associates
Houston, Texas, United States
Village Pediatrics
Plano, Texas, United States
Pediatric Center
Richmond, Texas, United States
CEVAXIN David
David, Chiriquí Province, Panama
CEVAXIN Chorrera
La Chorrera, Panamá Oeste Province, Panama
CEVAXIN Avenida Mexico
Panama City, Panama
CEVAXIN 24 de Diciembre
Panama City, Panama
Norfolk and Norwich University Hospitals
Norwich, United Kingdom