NCT07764237 A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
| NCT ID | NCT07764237 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ModernaTX, Inc. |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2026-08-11 |
| Primary Completion | 2027-07-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 375 participants in total. It began in 2026-08-11 with a primary completion date of 2027-07-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07764237 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07764237 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07764237 currently recruiting?
Yes, NCT07764237 is actively recruiting participants. Contact the research team at WeCareClinicalTrials@modernatx.com for enrollment information.
Where is the NCT07764237 trial being conducted?
This trial is being conducted at Québec, Canada, Victoriaville, Canada, Manchester, United Kingdom, Southampton, United Kingdom and 6 additional locations.
Who is sponsoring the NCT07764237 clinical trial?
NCT07764237 is sponsored by ModernaTX, Inc.. The trial plans to enroll 375 participants.