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0LR",{"type":110,"coordinates":245},[191,192],{"lat":192,"lon":191},{"type":248,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655233","phase-2-phase-2b-study-of-a-respiratory-syncytial-virus-and-human-metapneumovirus-rsvhmpv-protein-vaccine-candidate-in-adults-60-years-of-age-and-older-100655233",false,"NCT07810010","Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older","A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)","Inclusion Criteria:\n\n* Aged 60 years or older on the day of inclusion\n* Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion\n\nExclusion Criteria:\n\n* Known\u002Fsuspected immunodeficiency; immunosuppressive therapy\u002Fimmunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded\n* Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion\n* Previous history of Guillain-Barré Syndrome (GBS)\n* Previous vaccination against RSV and\u002For HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and\u002For HMPV monoclonal antibody\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",true,"ALL","60 Years",{"count":260,"type":261},8000,"ESTIMATED","INTERVENTIONAL",[264],"PHASE2","Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.\n\nThe study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).\n\nThe enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.",[267,268,269],"Respiratory Syncytial Virus","Human Metapneumovirus","Healthy Volunteers","2026-09-15",{"date":272,"type":273},"2026-09-16","ACTUAL",{"date":275,"type":273},"2026-09-09",{"date":277,"type":261},"2028-07-05",{"name":5,"class":6},16]