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Active Not RecruitingNCT07117487

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

A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
507 (actual)
Sponsor
ModernaTX, Inc. · Industry
Sex
All
Age
60 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALmRNA-1345Suspension for injection

Timeline

Start date
2025-08-05
Primary completion
2026-04-15
Completion
2026-04-15
First posted
2025-08-12
Last updated
2026-01-30

Locations

11 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07117487. Inclusion in this directory is not an endorsement.

A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in (NCT07117487) · Clinical Trials Directory