[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592760":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":55,"overallOfficials":11,"centralContacts":62,"locations":70,"responsibleParty":87,"collaborators":11,"id":89,"slug":11,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":11,"studyType":102,"phases":103,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"GC Biopharma Corp","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":11},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Solicited adverse events occurring by day 14 after administration of the investigational product",null,"14 days after administration of the IP",{"measure":14,"description":11,"timeFrame":15},"Unsolicited adverse events occurring by day 28 after administration of the investigational product","28 days after administration of the IP",{"measure":17,"description":11,"timeFrame":18},"Acute adverse events occurring within 30 minutes after administration of the investigational product","30 minutes after administration of the IP",{"measure":20,"description":11,"timeFrame":21},"Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product","180 days after administration of the IP",{"measure":23,"description":11,"timeFrame":15},"Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations",[25,27,30],{"measure":26,"description":11,"timeFrame":15},"Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product",{"measure":28,"description":29,"timeFrame":15},"Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product","Boosting response rate: 1) If less than 0.1 IU\u002Fml before vaccination, it should be 0.4 IU\u002Fml or higher after the vaccination, or 2) if not less than 0.1 IU\u002Fml before vaccination, it should be 4 times or higher after the vaccination.",{"measure":31,"description":11,"timeFrame":15},"Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":37,"maskingDescription":11,"whoMasked":38},"TRIPLE",[39,40,41],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"GC3111B","EXPERIMENTAL","Participants randomized to receive a single dose of GC3111B vaccine.",[48],"Biological: GC3111B",{"label":50,"type":51,"description":52,"interventionNames":53},"Boostrix®","ACTIVE_COMPARATOR","Participants randomized to receive a single dose of Boostrix® vaccine.",[54],"Biological: Boostrix®",[56,60],{"type":57,"name":44,"description":58,"armGroupLabels":59,"otherNames":11},"BIOLOGICAL","0.5 mL, Intramuscular injection",[44],{"type":57,"name":50,"description":58,"armGroupLabels":61,"otherNames":11},[50],[63,68],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Minji Ko","CONTACT","+82-31-260-9143","minji.ko@gccorp.com",{"name":69,"role":65,"phone":11,"phoneExt":11,"email":11},"Sujin Lee",[71],{"facility":72,"status":73,"city":74,"state":11,"zip":75,"country":76,"countryCode":11,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital","RECRUITING","Seoul","1021","South Korea",{"type":78,"coordinates":79},"Point",[80,81],126.9784,37.566,{"lat":81,"lon":80},[84],{"name":85,"role":86,"phone":11,"phoneExt":11,"email":11},"Junghyun Choi, MD, PhD.","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":100,"type":101},120,"ESTIMATED","INTERVENTIONAL",[104,105],"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.",[108],"Tetanus-diphtheria-acellular Pertussis (Tdap)","2025-07-08",{"date":111,"type":112},"2025-07-10","ACTUAL",{"date":114,"type":112},"2025-06-05",{"date":116,"type":101},"2026-05",{"name":5,"class":6},1]