[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649303":3},{"organization":4,"armGroups":7,"interventions":62,"overallOfficials":68,"centralContacts":84,"locations":91,"responsibleParty":263,"collaborators":68,"id":265,"slug":266,"hasResults":267,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":68,"eligibilityCriteria":271,"healthyVolunteers":272,"sex":273,"minAge":274,"maxAge":68,"enrollmentInfo":275,"targetDuration":68,"studyType":278,"phases":279,"briefSummary":282,"conditions":283,"keywords":287,"overallStatus":94,"whyStopped":68,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,18,22,26,30,34,40,46,52,57],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: RSV + HMPV Vaccine-Dose 1","EXPERIMENTAL","Participants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio",[13],"Biological: RSV+HMPV vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: RSV + HMPV Vaccine-Dose 2","Participants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: RSV + HMPV Vaccine-Dose 3","Participants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4: RSV + HMPV Vaccine-Dose 4","Participants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Group 5: RSV + HMPV Vaccine-Dose 5","Participants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Group 6: RSV + HMPV Vaccine-Dose 6","Participants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio",[13],{"label":35,"type":36,"description":37,"interventionNames":38},"Group 7: Control Vaccine 1","ACTIVE_COMPARATOR","Participants will receive control vaccine 1",[39],"Biological: Control Vaccine 1",{"label":41,"type":42,"description":43,"interventionNames":44},"Group 8: Placebo","PLACEBO_COMPARATOR","Participants will receive Placebo",[45],"Other: Placebo",{"label":47,"type":48,"description":49,"interventionNames":50},"Group 9: Control Vaccine 2","OTHER","Participants will receive control vaccine 2 at a predefined dose and antigen ratio",[51],"Biological: Control Vaccine 2",{"label":53,"type":48,"description":54,"interventionNames":55},"Group 10: Control Vaccine 3","Participants will receive control vaccine 3 at a predefined dose",[56],"Biological: Control Vaccine 3",{"label":58,"type":48,"description":59,"interventionNames":60},"Group 11: Control Vaccine 4","Participants will receive control vaccine 4 at a predefined dose",[61],"Biological: Control Vaccine 4",[63,69,72,75,78,81],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"BIOLOGICAL","RSV+HMPV vaccine","RSV + HMPV Candidate Vaccine",[9,15,19,23,27,31],null,{"type":64,"name":70,"description":70,"armGroupLabels":71,"otherNames":68},"Control Vaccine 3",[53],{"type":64,"name":73,"description":73,"armGroupLabels":74,"otherNames":68},"Control Vaccine 4",[58],{"type":64,"name":76,"description":76,"armGroupLabels":77,"otherNames":68},"Control Vaccine 2",[47],{"type":48,"name":79,"description":79,"armGroupLabels":80,"otherNames":68},"Placebo",[41],{"type":64,"name":82,"description":82,"armGroupLabels":83,"otherNames":68},"Control Vaccine 1",[35],[85],{"name":86,"role":87,"phone":88,"phoneExt":89,"email":90},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[92,106,116,126,135,145,155,165,175,185,195,205,215,225,235,244,253],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":68},"Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025","RECRUITING","Gadsden","Alabama","35901","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-86.00639,34.01434,{"lat":104,"lon":103},{"facility":107,"status":94,"city":108,"state":109,"zip":110,"country":98,"countryCode":99,"cosmosGeoPoint":111,"geoPoint":115,"contacts":68},"Scottsdale Clinical Trials- Site Number : 8400011","Scottsdale","Arizona","85260",{"type":101,"coordinates":112},[113,114],-111.89903,33.50921,{"lat":114,"lon":113},{"facility":117,"status":94,"city":118,"state":119,"zip":120,"country":98,"countryCode":99,"cosmosGeoPoint":121,"geoPoint":125,"contacts":68},"Long Beach Research Institute- Site Number : 8400005","Long Beach","California","90805",{"type":101,"coordinates":122},[123,124],-118.18923,33.76696,{"lat":124,"lon":123},{"facility":127,"status":94,"city":128,"state":119,"zip":129,"country":98,"countryCode":99,"cosmosGeoPoint":130,"geoPoint":134,"contacts":68},"Alliance Clinical - San Diego- Site Number : 8400033","San Diego","92120",{"type":101,"coordinates":131},[132,133],-117.16472,32.71571,{"lat":133,"lon":132},{"facility":136,"status":94,"city":137,"state":138,"zip":139,"country":98,"countryCode":99,"cosmosGeoPoint":140,"geoPoint":144,"contacts":68},"Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064","DeLand","Florida","32720",{"type":101,"coordinates":141},[142,143],-81.30312,29.02832,{"lat":143,"lon":142},{"facility":146,"status":94,"city":147,"state":148,"zip":149,"country":98,"countryCode":99,"cosmosGeoPoint":150,"geoPoint":154,"contacts":68},"Accel Research Sites - NeuroStudies- Site Number : 8400063","Decatur","Georgia","30030",{"type":101,"coordinates":151},[152,153],-84.29631,33.77483,{"lat":153,"lon":152},{"facility":156,"status":94,"city":157,"state":158,"zip":159,"country":98,"countryCode":99,"cosmosGeoPoint":160,"geoPoint":164,"contacts":68},"DM Clinical Research - Chicago- Site Number : 8400050","Melrose Park","Illinois","60160",{"type":101,"coordinates":161},[162,163],-87.85673,41.90059,{"lat":163,"lon":162},{"facility":166,"status":94,"city":167,"state":168,"zip":169,"country":98,"countryCode":99,"cosmosGeoPoint":170,"geoPoint":174,"contacts":68},"DM Clinical Research - Detroit- Site Number : 8400049","Southfield","Michigan","48076",{"type":101,"coordinates":171},[172,173],-83.22187,42.47337,{"lat":173,"lon":172},{"facility":176,"status":94,"city":177,"state":178,"zip":179,"country":98,"countryCode":99,"cosmosGeoPoint":180,"geoPoint":184,"contacts":68},"Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016","Lincoln","Nebraska","68510",{"type":101,"coordinates":181},[182,183],-96.66696,40.8,{"lat":183,"lon":182},{"facility":186,"status":94,"city":187,"state":188,"zip":189,"country":98,"countryCode":99,"cosmosGeoPoint":190,"geoPoint":194,"contacts":68},"Alliance Clinical - Las Vegas- Site Number : 8400034","Las Vegas","Nevada","89109",{"type":101,"coordinates":191},[192,193],-115.13722,36.17497,{"lat":193,"lon":192},{"facility":196,"status":94,"city":197,"state":198,"zip":199,"country":98,"countryCode":99,"cosmosGeoPoint":200,"geoPoint":204,"contacts":68},"Hawthorne Health - Staten Island- Site Number : 8400026","Staten Island","New York","10309",{"type":101,"coordinates":201},[202,203],-74.13986,40.56233,{"lat":203,"lon":202},{"facility":206,"status":94,"city":207,"state":208,"zip":209,"country":98,"countryCode":99,"cosmosGeoPoint":210,"geoPoint":214,"contacts":68},"DM Clinical Research - Philadelphia- Site Number : 8400046","Philadelphia","Pennsylvania","19107",{"type":101,"coordinates":211},[212,213],-75.16362,39.95238,{"lat":213,"lon":212},{"facility":216,"status":94,"city":217,"state":218,"zip":219,"country":98,"countryCode":99,"cosmosGeoPoint":220,"geoPoint":224,"contacts":68},"Coastal Carolina Research Center - North Charleston- Site Number : 8400061","North Charleston","South Carolina","29405",{"type":101,"coordinates":221},[222,223],-79.97481,32.85462,{"lat":223,"lon":222},{"facility":226,"status":94,"city":227,"state":228,"zip":229,"country":98,"countryCode":99,"cosmosGeoPoint":230,"geoPoint":234,"contacts":68},"Velocity Clinical Research - Austin- Site Number : 8400013","Austin","Texas","78759",{"type":101,"coordinates":231},[232,233],-97.74306,30.26715,{"lat":233,"lon":232},{"facility":236,"status":94,"city":237,"state":228,"zip":238,"country":98,"countryCode":99,"cosmosGeoPoint":239,"geoPoint":243,"contacts":68},"DM Clinical Research - Sugar Land- Site Number : 8400048","Sugar Land","77478",{"type":101,"coordinates":240},[241,242],-95.63495,29.61968,{"lat":242,"lon":241},{"facility":245,"status":94,"city":246,"state":228,"zip":247,"country":98,"countryCode":99,"cosmosGeoPoint":248,"geoPoint":252,"contacts":68},"DM Clinical Research - Tomball- Site Number : 8400045","Tomball","77375",{"type":101,"coordinates":249},[250,251],-95.61605,30.09716,{"lat":251,"lon":250},{"facility":254,"status":94,"city":255,"state":256,"zip":257,"country":98,"countryCode":99,"cosmosGeoPoint":258,"geoPoint":262,"contacts":68},"Charlottesville Medical Research- Site Number : 8400062","Charlottesville","Virginia","22911",{"type":101,"coordinates":259},[260,261],-78.47668,38.02931,{"lat":261,"lon":260},{"type":264,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR","100649303","phase-1-phase-12-study-of-respiratory-syncytial-virus-and-human-metapneumovirus-rsvhmpv-vaccine-candidate-in-adults-60-years-of-age-and-older-100649303",false,"NCT07734649","Phase 1\u002F2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older","A Phase 1\u002F2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent 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* Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)\n\nExclusion Criteria:\n\n* History of laboratory-confirmed RSV and\u002For laboratory-confirmed HMPV infection affecting the participant and\u002For the participant's household in the previous 12 months\n* Previous history of myocarditis, pericarditis, and\u002For myopericarditis\n* Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and\u002For myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results\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\n* Any vaccine given 4 weeks before or 4 weeks after study intervention\n* Previous vaccination against RSV and\u002For HMPV with an investigational or marketed vaccine\n* Receipt of any mRNA vaccine\u002Fproduct in the 2 months preceding study intervention administration\n* Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months\n* Any screening laboratory parameter with laboratory abnormality \\> Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL","60 Years",{"count":276,"type":277},2400,"ESTIMATED","INTERVENTIONAL",[280,281],"PHASE1","PHASE2","This study is a Phase 1\u002F2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved\u002Flicensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.\n\nThe study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \\[6 dose levels\\], placebo and 4 control groups).\n\nThe duration of the study will be approximately 12 months for each participant.",[284,285,286],"Respiratory Syncytial Virus Immunization","Human Metapneumovirus Immunization","Healthy Volunteers",[288,289],"RSV","HMPV","2026-07-27",{"date":292,"type":293},"2026-07-29","ACTUAL",{"date":295,"type":293},"2026-07-22",{"date":297,"type":277},"2028-05-03",{"name":5,"class":6},17]