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

RecruitingPhase 1Ages 60 Years - anyAllModernaTX, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • mRNA-1365 (Profile 2)
  • mRNA-1345 (Profile 1)
  • mRNA-1345 (Profile 3)
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Where

10 sites
Diex Recherche Quebec
Québec, Canada
Diex Recherche Victoraville
Victoriaville, Canada
MAC Clinical Research
Manchester, United Kingdom
Southampton General Hospital, NHS
Southampton, United Kingdom
Norfolk and Norwich University Hospital, NHS
Norwich, United Kingdom
University Hospital Birmingham, NHS
Birmingham, United Kingdom
Royal Free Hospital, NHS
London, United Kingdom
Guys and St. Thomas Hospital, NHS
London, United Kingdom

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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