Clinical Trials in the UK / NCT07764237
Recruiting
Phase 1
A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
NCT07764237 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Respiratory Syncytial Virus (RSV)Human Metapneuomovirus (hMPV)
Investigational drug(s) / intervention(s)
mRNA-1365 (Profile 2): Sterile liquid for injection
mRNA-1345 (Profile 1): Sterile liquid for injection
mRNA-1345 (Profile 3): Sterile liquid for injection
Study summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Eligibility
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.
Primary outcome measure(s)
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Up to Day 7 (the day of study intervention and 6 subsequent days)
- Number of Participants with Unsolicited Adverse Events (AEs) — 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) — Up to End of Study (EOS) (Day 181)
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Diex Recherche Quebec | Québec | Quebec | Recruiting |
| Diex Recherche Victoraville | Victoriaville | Quebec | Recruiting |
| MAC Clinical Research | Manchester | Greater Manchester | Not Yet Recruiting |
| Southampton General Hospital, NHS | Southampton | Hampshire | Not Yet Recruiting |
| Norfolk and Norwich University Hospital, NHS | Norwich | Norfolk | Not Yet Recruiting |
| University Hospital Birmingham, NHS | Birmingham | West Midlands | Not Yet Recruiting |
| Royal Free Hospital, NHS | London | United Kingdom | Not Yet Recruiting |
| Guys and St. Thomas Hospital, NHS | London | United Kingdom | Not Yet Recruiting |
| St. George University Hospital, NHS | London | United Kingdom | Not Yet Recruiting |
| Royal Victoria Infirmary, NHS | Newcastle | United Kingdom | Not Yet Recruiting |
More ModernaTX, Inc. trials in the UK
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07764237 on ClinicalTrials.gov ↗ ← All trials in the UK