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

Last updated: January 28, 2026
Sponsor: ModernaTX, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

mRNA-1345

Clinical Study ID

NCT07117487
mRNA-1345-P306
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants may have one or more chronic medical diagnoses, but should be medicallystable as assessed by:

  • Absence of changes in medical therapy within 60 days of Visit 1 due totreatment failure or toxicity.

  • Absence of serious or significant medical events within 30 days of Visit 1.

  • Absence of known, current, and life-limiting diagnoses which, in the opinion ofthe Investigator, would make completion of the protocol unlikely.

  • Participant has received a single dose of Arexvy or Abrysvo at least 12 months priorto Visit 1. Participants must provide proof of RSV vaccination status (includingbrand and date received) prior to enrollment.

Exclusion

Key Exclusion Criteria:

  • Participant has received or plans to receive any vaccine authorized or approved by alocal health agency ≤14 days prior to study injection (Day 1) or plans to receive avaccine authorized or approved by a local health agency within 14 days after thestudy injection. Nonstudy vaccination(s) should not be delayed.

  • Prior participation in research involving receipt of any investigational RSV product (drug/biologic).

  • Has received systemic immunoglobulins, long-acting biological therapies that affectimmune responses (for example, infliximab) or blood products within 90 days prior toVisit 1 or plans to receive them during the study.

Other protocol-specified inclusion and/or exclusion criteria may apply.

Study Design

Total Participants: 507
Treatment Group(s): 1
Primary Treatment: mRNA-1345
Phase: 3
Study Start date:
August 05, 2025
Estimated Completion Date:
April 15, 2026

Connect with a study center

  • Velocity Clinical Research, Denver

    Denver, Colorado 80110
    United States

    Site Not Available

  • Velocity Clinical Research, Denver

    Denver 5419384, Colorado 5417618 80110
    United States

    Site Not Available

  • Indago Research & Health Center, Inc.

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Indago Research & Health Center, Inc.

    Hialeah 4158476, Florida 4155751 33012
    United States

    Site Not Available

  • Velocity Clinical Research, Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research, Savannah

    Savannah 4221552, Georgia 4197000 31406
    United States

    Site Not Available

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Velocity Clinical Research, Valparaiso

    Valparaiso 4927537, Indiana 4921868 46383
    United States

    Site Not Available

  • Velocity Clinical Research, Covington

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Velocity Clinical Research, Covington

    Covington 4321005, Louisiana 4331987 70433
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville

    Rockville 4367175, Maryland 4361885 20854
    United States

    Site Not Available

  • Velocity Clinical Research, Lincoln

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Velocity Clinical Research, Lincoln

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford 5740099, Oregon 5744337 97504
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Austin 4671654, Texas 4736286 78759
    United States

    Site Not Available

  • Velocity Clinical Research, Hampton

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Velocity Clinical Research, Hampton

    Hampton 4762894, Virginia 6254928 23666
    United States

    Site Not Available

  • Velocity Clinical Research, Spokane

    Spokane, Washington 99218
    United States

    Site Not Available

  • Velocity Clinical Research, Spokane

    Spokane 5811696, Washington 5815135 99218
    United States

    Site Not Available

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