RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-08-05
Study Completion:2026-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07117487

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
  2. * Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity.
  3. * Absence of serious or significant medical events within 30 days of Visit 1.
  4. * Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
  5. * Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.
  1. * Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
  2. * Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
  3. * Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.

Contacts and Locations

Study Contact

Moderna WeCare Team
CONTACT
1-866-663-3762
WeCareClinicalTrials@modernatx.com

Study Locations (Sites)

Velocity Clinical Research, Denver
Denver, Colorado, 80110
United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
United States
Velocity Clinical Research, Covington
Covington, Louisiana, 70433
United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
United States
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, 68510
United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504
United States
Velocity Clinical Research, Austin
Austin, Texas, 78759
United States
Velocity Clinical Research, Hampton
Hampton, Virginia, 23666
United States
Velocity Clinical Research, Spokane
Spokane, Washington, 99218
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2026-04-15

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2026-04-15

Terms related to this study

Keywords Provided by Researchers

  • Viral Diseases
  • Messenger RNA
  • Moderna
  • mRNA-1345
  • Respiratory syncytial virus
  • Safety
  • Vaccines

Additional Relevant MeSH Terms

  • Respiratory Syncytial Virus