Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07764237

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Diex Recherche Quebec, Québec, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA-1365 (Profile 2)

Biological

Sterile liquid for injection

mRNA-1345 (Profile 1)

Biological

Sterile liquid for injection

mRNA-1345 (Profile 3)

Biological

Sterile liquid for injection

Primary outcomes

  1. 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)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Up to Day 28 (the day of study intervention and 27 subsequent days)

  3. 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)

Secondary outcomes

  1. Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)

    Time frame: Day 29

  2. Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)

    Time frame: Day 29

  3. Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level

    Time frame: Day 29

Study contacts

Contact information is provided by the study sponsor or research team.

Moderna WeCareTeam

CONTACT

[email protected]

1-866-663-3762

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.