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NOT YET RECRUITING
NCT07764237
PHASE1

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

375

Start Date

2026-08-16

Completion Date

2027-07-20

Last Updated

2026-08-13

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

mRNA-1365 (Profile 2)

Sterile liquid for injection

BIOLOGICAL

mRNA-1345 (Profile 1)

Sterile liquid for injection

BIOLOGICAL

mRNA-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