A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
← catalyst calendarNCT07764237 · readout in 334 d
Sponsored by ModernaTX, Inc. (industry) · MRNA — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
375estimated
Sites
10
Countries
Canada, United Kingdom
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-11 | actual | When the study began enrolling |
| Primary completion | 2027-07-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-07-20 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Respiratory Syncytial Virus (RSV)
- Human Metapneuomovirus (hMPV)
Interventions
- Biological: mRNA-1365 (Profile 2)
- Biological: mRNA-1345 (Profile 1)
- Biological: mRNA-1345 (Profile 3)
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
measured Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
measured Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
measured Up to End of Study (EOS) (Day 181)
Permalink · MRNA's whole pipeline · Catalyst calendar · Every registered study · What changed