A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults

August 18, 2026 updated by: ModernaTX, Inc.

A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age

The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

375

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4T3
        • Recruiting
        • Diex Recherche Québec
      • Victoriaville, Quebec, Canada, G6P 3Z8
        • Recruiting
        • Diex Recherche Victoraville
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • Royal Free Hospital, NHS
      • London, United Kingdom, SE1 7EH
        • Not yet recruiting
        • Guys and St. Thomas Hospital, NHS
      • London, United Kingdom, SW17 0RE
        • Not yet recruiting
        • St. George University Hospital, NHS
      • Newcastle, United Kingdom, NE1 4LP
        • Not yet recruiting
        • Royal Victoria Infirmary, NHS
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9NQ
        • Not yet recruiting
        • MAC Clinical Research
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Not yet recruiting
        • Southampton General Hospital, NHS
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UQ
        • Not yet recruiting
        • Norfolk and Norwich University Hospital, NHS
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Not yet recruiting
        • University Hospital Birmingham, NHS

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
  • Body mass index within the range 18.5 to 35 kg/m2 (inclusive).

Key Exclusion Criteria:

  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
  • Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade 1.
  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
  • History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
  • Participants with immune-mediated (autoimmune) conditions are generally excluded.
  • Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past.

Note: Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-1365 (Profile 2) Dose Level 1
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1.
Biological: mRNA-1365 (Profile 2)
Sterile liquid for injection
Experimental: mRNA-1365 (Profile 2) Dose Level 2
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1.
Biological: mRNA-1365 (Profile 2)
Sterile liquid for injection
Experimental: mRNA-1365 (Profile 2) Dose Level 3
Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1.
Biological: mRNA-1365 (Profile 2)
Sterile liquid for injection
Active Comparator: mRNA-1345 (Profile 1)
Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.
Biological: mRNA-1345 (Profile 1)
Sterile liquid for injection
Active Comparator: mRNA-1345 (Profile 3)
Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.
Biological: mRNA-1345 (Profile 3)
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 7 (the day of study intervention and 6 subsequent days)
Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 28 (the day of study intervention and 27 subsequent days)
Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Time Frame: Up to End of Study (EOS) (Day 181)
Up to End of Study (EOS) (Day 181)

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)
Time Frame: Day 29
Day 29
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)
Time Frame: Day 29
Day 29
Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

August 11, 2026

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

July 20, 2027

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 13, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1365P2-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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