[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580900":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":46,"locations":52,"responsibleParty":123,"collaborators":36,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":36,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":36,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":36,"overallStatus":55,"whyStopped":36,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},{"fullName":5,"class":6},"Clover Biopharmaceuticals, Ltd","INDUSTRY",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (SCB-1019T)","EXPERIMENTAL","50 adults to receive low dose SCB-1019T at Day 1",[13],"Biological: Candidate vaccine, SCB-1019T",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 (SCB-1019T)","50 adults to receive high dose SCB-1019T at Day 1",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Group 3 (AREXVY)","ACTIVE_COMPARATOR","50 adults to receive AREXVY at Day 1",[23],"Biological: AREXVY",{"label":25,"type":26,"description":27,"interventionNames":28},"Group 4 (Placebo)","PLACEBO_COMPARATOR","10 adults to receive Placebo at Day 1",[29],"Other: placebo",[31,37,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","Candidate vaccine, SCB-1019T","SCB-1019T is a novel bivalent recombinant RSV vaccine (CHO Cell) designed to broadly neutralize the two dominant circulating strains of the virus. The SCB-1019T vaccine consists of the PreF protein subunits from the two dominant circulating strains, strain A and strain B, fused to Trimer-Tag™.",[9,15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"AREXVY","positive comparator",[19],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"OTHER","placebo","Placebo Comparator",[25],[47],{"name":48,"role":49,"phone":50,"phoneExt":36,"email":51},"Xuesong Pei, MD","CONTACT","(+86) 18515445890","xuesong.pei@cloverbiopharma.com",[53,72,85,98,111],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"AMR Phoenix","RECRUITING","Phoenix","Arizona","85282","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-112.07404,33.44838,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":70,"phoneExt":36,"email":71},"William Reedy, MD","615-591-0211","amrteam@amrllc.com",{"facility":73,"status":55,"city":74,"state":75,"zip":76,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"AMR Fort Myers","Fort Myers","Florida","33912",{"type":62,"coordinates":78},[79,80],-81.84059,26.62168,{"lat":80,"lon":79},[83],{"name":84,"role":49,"phone":70,"phoneExt":36,"email":71},"Pedro Ylisastigui, MD",{"facility":86,"status":55,"city":87,"state":88,"zip":89,"country":59,"countryCode":60,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"AMR Lexington","Lexington","Kentucky","40509",{"type":62,"coordinates":91},[92,93],-84.47772,37.98869,{"lat":93,"lon":92},[96],{"name":97,"role":49,"phone":70,"phoneExt":36,"email":71},"Mark Adams, MD",{"facility":99,"status":55,"city":100,"state":101,"zip":102,"country":59,"countryCode":60,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"AMR Kansas City","Kansas City","Missouri","64114",{"type":62,"coordinates":104},[105,106],-94.57857,39.09973,{"lat":106,"lon":105},[109],{"name":110,"role":49,"phone":70,"phoneExt":36,"email":71},"Martha Sue Fanning, MD",{"facility":112,"status":55,"city":112,"state":113,"zip":114,"country":59,"countryCode":60,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Knoxville","Tennessee","37909",{"type":62,"coordinates":116},[117,118],-83.92074,35.96064,{"lat":118,"lon":117},[121],{"name":122,"role":49,"phone":70,"phoneExt":36,"email":71},"Jerry B. Punch, MD",{"type":124,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100580900","phase-1-safety-and-immunogenicity-study-of-revaccination-with-scb-1019t-in-healthy-adults-100580900",false,"NCT06843317","Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults","A Phase 1, Placebo-controlled, Randomized, Observer-blind Study to Describe the Safety, Tolerability and Immunogenicity of SCB-1019T in Adults Who Were Vaccinated With AREXVY at Least 18 Months Before","Inclusion Criteria:\n\n1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.\n2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.\n3. Individuals willing and able to give an informed consent, prior to screening.\n4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).\n\nPlease refer to Protocol for full list of Inclusion and Exclusion criteria.\n\nExclusion Criteria:\n\n1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and\u002For fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.\n2. Recurrent or un-controlled neurological disorders or seizures.\n3. Serious or unstable chronic illnesses\n4. Any history of dementia or any medical condition that moderately or severely impairs cognition\n5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.\n\nPlease refer to Protocol for full list of Inclusion and Exclusion criteria.",true,"ALL","60 Years","85 Years",{"count":137,"type":138},160,"ESTIMATED","INTERVENTIONAL",[141],"PHASE1","CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.",[144],"RSV Infection","2025-05-13",{"date":147,"type":148},"2025-05-14","ACTUAL",{"date":150,"type":148},"2025-03-21",{"date":152,"type":138},"2026-06-03",{"name":154,"class":6},"Clover Biopharmaceuticals USA, LLC",5]