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
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
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.
[{"measure":"Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)","timeFrame":"Up to Day 7 (the day of study intervention and 6 subsequent days)"},{"measure":"Number of Participants with Unsolicited Adverse Events (AEs)","timeFrame":"Up to Day 28 (the day of study intervention and 27 subsequent days)"},{"measure":"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)","timeFrame":"Up to End of Study (EOS) (Day 181)"}]