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ACTIVE NOT RECRUITING
NCT05743881
PHASE1

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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

BIOLOGICAL

mRNA-1345

Sterile liquid for injection

BIOLOGICAL

mRNA-1365

Sterile liquid for injection

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) solution for injection

DRUG

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