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ACTIVE NOT RECRUITING
NCT07117487
PHASE3

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

507

Start Date

2025-08-05

Completion Date

2026-04-15

Last Updated

2026-01-30

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

mRNA-1345

Suspension for injection

Locations (11)

Velocity Clinical Research, Denver

Denver, Colorado, United States

Indago Research & Health Center, Inc.

Hialeah, Florida, United States

Velocity Clinical Research, Savannah

Savannah, Georgia, United States

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, United States

Velocity Clinical Research, Covington

Covington, Louisiana, United States

Velocity Clinical Research, Rockville

Rockville, Maryland, United States

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Velocity Clinical Research, Austin

Austin, Texas, United States

Velocity Clinical Research, Hampton

Hampton, Virginia, United States

Velocity Clinical Research, Spokane

Spokane, Washington, United States