[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592760":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":36,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"GC Biopharma Corp","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GC3111B","EXPERIMENTAL","Participants randomized to receive a single dose of GC3111B vaccine.",[13],"Biological: GC3111B",{"label":15,"type":16,"description":17,"interventionNames":18},"Boostrix®","ACTIVE_COMPARATOR","Participants randomized to receive a single dose of Boostrix® vaccine.",[19],"Biological: Boostrix®",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","0.5 mL, Intramuscular injection",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Minji Ko","CONTACT","+82-31-260-9143","minji.ko@gccorp.com",{"name":35,"role":31,"phone":25,"phoneExt":25,"email":25},"Sujin Lee",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":25,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital","RECRUITING","Seoul","1021","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":25,"phoneExt":25,"email":25},"Junghyun Choi, MD, PhD.","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100592760","phase-1-a-phase-iii-study-to-evaluate-the-safety-and-immunogenicity-of-gc3111b-in-healthy-adults-100592760",false,"NCT06997627","A Phase I\u002FII Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults","An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I\u002FII Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults","Inclusion Criteria:\n\n* Healthy adults aged 19 to 64 years old as of the date of written consent.\n* Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.\n\nExclusion Criteria:\n\n* Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.\n* Individuals with a history of Tdap vaccination prior to administration of the investigational product.\n* Pregnant and breastfeeding women.\n* Individuals who have participated in other clinical trials involving investigational products\u002Fdevices within 6 months prior to administration of the investigational product.",true,"ALL","19 Years","64 Years",{"count":67,"type":68},120,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.",[75],"Tetanus-diphtheria-acellular Pertussis (Tdap)","2025-07-08",{"date":78,"type":79},"2025-07-10","ACTUAL",{"date":81,"type":79},"2025-06-05",{"date":83,"type":68},"2026-05",{"name":5,"class":6},1]