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NCT05743881Phase 1ACTIVE NOT RECRUITING

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

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
Respiratory Syncytial VirusHuman Metapneumovirus
Interventions / Drugs
mRNA-1345mRNA-1365PlaceboNimenrix
View on ClinicalTrials.gov ↗
Sponsor
MRNA
Moderna Inc
mRNA Therapeutics
C64/100
Study Details
Enrollment186 participants
Primary Completion—
Lead SponsorModernaTX, Inc.
Data Retrieved2026-04-11 02:55:38.209299+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 186 participants
Sponsor Catalyst Profile

Moderna Inc (MRNA) is the sponsoring company for this trial. BiotechSign currently grades this company C (64/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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