A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Prevention
Enrollment
507actual
Sites
11
Country
United States
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 | 2025-08-05 | actual | When the study began enrolling |
| Primary completion | 2026-03-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-27 | actual | The whole study's end, after follow-up |
| First posted | 2025-08-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Respiratory Syncytial Virus
Intervention
- Biological: mRNA-1345
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
measured Day 1 up to Day 7 (7 days post-injection)
Number of Participants with Unsolicited Adverse Events (AEs)
measured Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
measured Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
measured Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
measured Day 29
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