Recruiting
Phase 1

Observational Study

Sponsor:

Moderna

Code:

NCT07764237

Conditions

Respiratory Syncytial Virus (RSV)

Human Metapneuomovirus (hMPV)

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

mRNA-1365 (Profile 2)

mRNA-1345 (Profile 1)

mRNA-1345 (Profile 3)

Study Details

Brief summary:

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

Conditions

Respiratory Syncytial Virus (RSV)

Human Metapneuomovirus (hMPV)

Study ID

NCT07764237

Start date

Aug 11, 2026

Status verified date

Aug, 2026

Completion date

Jul 20, 2027

Anticipated

Primary completion date

Jul 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

375 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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.

active comparator: mRNA-1345 (Profile 1)

Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.

active comparator: mRNA-1345 (Profile 3)

Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.

Interventions

mRNA-1365 (Profile 2)

Sterile liquid for injection

mRNA-1345 (Profile 1)

Sterile liquid for injection

mRNA-1345 (Profile 3)

Sterile liquid for injection

Primary outcome measure

  • 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) ]
  • Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Moderna WeCareTeam

1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

Diex Recherche Quebec

Recruiting

Québec, Quebec, Canada, G1V 4T3

Diex Recherche Victoraville

Recruiting

Victoriaville, Quebec, Canada, G6P 3Z8

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Respiratory Syncytial Virus (RSV)
  • Human Metapneuomovirus (hMPV)
  • Vaccine
  • Moderna
  • Respiratory Viral Infection
  • mRNA-1365 (Profile 2)
  • Older Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-08-19.