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A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
Sponsor: ModernaTX, Inc.
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
mRNA-1365 (Profile 2)
Sterile liquid for injection
mRNA-1345 (Profile 1)
Sterile liquid for injection
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