[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651565":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":147,"collaborators":39,"id":149,"slug":150,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":39,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":157,"minAge":158,"maxAge":39,"enrollmentInfo":159,"targetDuration":39,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":53,"whyStopped":39,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"ModernaTX, Inc.","INDUSTRY",[8,14,18,22,28],{"label":9,"type":10,"description":11,"interventionNames":12},"mRNA-1365 (Profile 2) Dose Level 1","EXPERIMENTAL","Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1.",[13],"Biological: mRNA-1365 (Profile 2)",{"label":15,"type":10,"description":16,"interventionNames":17},"mRNA-1365 (Profile 2) Dose Level 2","Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"mRNA-1365 (Profile 2) Dose Level 3","Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"mRNA-1345 (Profile 1)","ACTIVE_COMPARATOR","Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1.",[27],"Biological: mRNA-1345 (Profile 1)",{"label":29,"type":24,"description":30,"interventionNames":31},"mRNA-1345 (Profile 3)","Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1.",[32],"Biological: mRNA-1345 (Profile 3)",[34,40,42],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BIOLOGICAL","mRNA-1365 (Profile 2)","Sterile liquid for injection",[9,15,19],null,{"type":35,"name":23,"description":37,"armGroupLabels":41,"otherNames":39},[23],{"type":35,"name":29,"description":37,"armGroupLabels":43,"otherNames":39},[29],[45],{"name":46,"role":47,"phone":48,"phoneExt":39,"email":49},"Moderna WeCareTeam","CONTACT","1-866-663-3762","WeCareClinicalTrials@modernatx.com",[51,65,74,87,97,107,117,126,132,138],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":39},"Diex Recherche Quebec","RECRUITING","Québec","Quebec","G1V 4T3","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-71.21454,46.81228,{"lat":63,"lon":62},{"facility":66,"status":53,"city":67,"state":55,"zip":68,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":73,"contacts":39},"Diex Recherche Victoraville","Victoriaville","G6P 3Z8",{"type":60,"coordinates":70},[71,72],-71.96579,46.05007,{"lat":72,"lon":71},{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":39},"MAC Clinical Research","NOT_YET_RECRUITING","Manchester","Greater Manchester","M13 9NQ","United Kingdom","UK",{"type":60,"coordinates":83},[84,85],-2.23743,53.48095,{"lat":85,"lon":84},{"facility":88,"status":76,"city":89,"state":90,"zip":91,"country":80,"countryCode":81,"cosmosGeoPoint":92,"geoPoint":96,"contacts":39},"Southampton General Hospital, NHS","Southampton","Hampshire","SO16 6YD",{"type":60,"coordinates":93},[94,95],-1.40428,50.90395,{"lat":95,"lon":94},{"facility":98,"status":76,"city":99,"state":100,"zip":101,"country":80,"countryCode":81,"cosmosGeoPoint":102,"geoPoint":106,"contacts":39},"Norfolk and Norwich University Hospital, NHS","Norwich","Norfolk","NR4 7UQ",{"type":60,"coordinates":103},[104,105],1.29834,52.62783,{"lat":105,"lon":104},{"facility":108,"status":76,"city":109,"state":110,"zip":111,"country":80,"countryCode":81,"cosmosGeoPoint":112,"geoPoint":116,"contacts":39},"University Hospital Birmingham, NHS","Birmingham","West Midlands","B15 2TH",{"type":60,"coordinates":113},[114,115],-1.89983,52.48142,{"lat":115,"lon":114},{"facility":118,"status":76,"city":119,"state":39,"zip":120,"country":80,"countryCode":81,"cosmosGeoPoint":121,"geoPoint":125,"contacts":39},"Royal Free Hospital, NHS","London","NW3 2QG",{"type":60,"coordinates":122},[123,124],-0.12574,51.50853,{"lat":124,"lon":123},{"facility":127,"status":76,"city":119,"state":39,"zip":128,"country":80,"countryCode":81,"cosmosGeoPoint":129,"geoPoint":131,"contacts":39},"Guys and St. Thomas Hospital, NHS","SE1 7EH",{"type":60,"coordinates":130},[123,124],{"lat":124,"lon":123},{"facility":133,"status":76,"city":119,"state":39,"zip":134,"country":80,"countryCode":81,"cosmosGeoPoint":135,"geoPoint":137,"contacts":39},"St. George University Hospital, NHS","SW17 0RE",{"type":60,"coordinates":136},[123,124],{"lat":124,"lon":123},{"facility":139,"status":76,"city":140,"state":39,"zip":141,"country":80,"countryCode":81,"cosmosGeoPoint":142,"geoPoint":146,"contacts":39},"Royal Victoria Infirmary, NHS","Newcastle","NE1 4LP",{"type":60,"coordinates":143},[144,145],-5.88979,54.21804,{"lat":145,"lon":144},{"type":148,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100651565","phase-1-a-study-to-investigate-safety-reactogenicity-and-immunogenicity-of-mrna-1365-profile-2-in-older-healthy-adults-100651565",false,"NCT07764237","A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults","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","Key Inclusion Criteria:\n\n* In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.\n* Body mass index within the range 18.5 to 35 kg\u002Fm2 (inclusive).\n\nKey Exclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.\n* Participants with immune-mediated (autoimmune) conditions are generally excluded.\n* Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and\u002For hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past.\n\nNote: Other inclusion and exclusion criteria may apply.",true,"ALL","60 Years",{"count":160,"type":161},375,"ESTIMATED","INTERVENTIONAL",[164],"PHASE1","The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups",[167,168],"Respiratory Syncytial Virus (RSV)","Human Metapneuomovirus (hMPV)",[167,168,170,171,172,36,173],"Vaccine","Moderna","Respiratory Viral Infection","Older Adults","2026-08-18",{"date":176,"type":177},"2026-08-19","ACTUAL",{"date":179,"type":177},"2026-08-11",{"date":181,"type":161},"2027-07-20",{"name":5,"class":6},10]