MedTrace Logo

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

NCT05743881 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Panama
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05743881 on ClinicalTrials.gov