NCT05743881

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 5 Months – 24 Months
• Healthy volunteers: Not accepted

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 Virus
• Human Metapneumovirus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-15
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2023-02-24
• Last updated: 2025-11-24

Locations

50 sites across 6 countries: United States, Australia, Canada, Panama, South Africa, United Kingdom

Regulatory

• FDA-regulated drug study