RecruitingPhase 1NCT07764237

A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults

A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age

Sponsor

ModernaTX, Inc.

Enrollment

375 participants

Start Date

Aug 11, 2026

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus (RSV)Human Metapneuomovirus (hMPV)

Summary

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called mRNA-1345 (Profile 1), a biological treatment called mRNA-1345 (Profile 3), and others for people with human metapneuomovirus (hmpv) and respiratory syncytial virus (rsv). The study is currently recruiting participants at 10 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALmRNA-1365 (Profile 2)

Sterile liquid for injection

BIOLOGICALmRNA-1345 (Profile 1)

Sterile liquid for injection

BIOLOGICALmRNA-1345 (Profile 3)

Sterile liquid for injection

Locations(10)

Diex Recherche Quebec

Québec, Quebec, Canada

Diex Recherche Victoraville

Victoriaville, Quebec, Canada

MAC Clinical Research

Manchester, Greater Manchester, United Kingdom

Southampton General Hospital, NHS

Southampton, Hampshire, United Kingdom

Norfolk and Norwich University Hospital, NHS

Norwich, Norfolk, United Kingdom

University Hospital Birmingham, NHS

Birmingham, West Midlands, United Kingdom

Royal Free Hospital, NHS

London, United Kingdom

Guys and St. Thomas Hospital, NHS

London, United Kingdom

St. George University Hospital, NHS

London, United Kingdom

Royal Victoria Infirmary, NHS

Newcastle, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07764237

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