[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471717":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":57,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":28,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":48,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},{"fullName":5,"class":6},"GC Biopharma Corp","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"MG1111(BARICELA) arm","EXPERIMENTAL","0.5ml, single dose, subcutaneous injection",[13],"Biological: MG1111 (BARICELA)",{"label":15,"type":16,"description":11,"interventionNames":17},"VARIVAX arm","ACTIVE_COMPARATOR",[18],"Biological: VARIVAX",{"label":20,"type":16,"description":11,"interventionNames":21},"Suduvax arm",[22],"Biological: Suduvax",[24,29,32],{"type":25,"name":26,"description":11,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","MG1111 (BARICELA)",[9],null,{"type":25,"name":30,"description":11,"armGroupLabels":31,"otherNames":28},"VARIVAX",[15],{"type":25,"name":33,"description":11,"armGroupLabels":34,"otherNames":28},"Suduvax",[20],[36],{"name":37,"affiliation":38,"role":39},"Yun-kyung Kim, M.D., Ph.D","Korea University Ansan Hospital","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":28,"email":45},"Hye Won Shin","CONTACT","+82-31-260-9032","hwshin27@gccorp.com",[47],{"facility":38,"status":48,"city":49,"state":28,"zip":28,"country":50,"countryCode":28,"cosmosGeoPoint":51,"geoPoint":56,"contacts":28},"RECRUITING","Ansan","South Korea",{"type":52,"coordinates":53},"Point",[54,55],126.52613,35.46836,{"lat":55,"lon":54},{"type":58,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100471717","phase-2-evaluate-the-safety-and-immunogenicity-after-mg1111baricela-inj-as-2nd-vaccination-in-4--6-year-old-healthy-children-with-a-history-of-1st-varicella-vaccination-100471717",false,"NCT05422508","Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination","A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination","Inclusion Criteria:\n\n* Healthy children between 4 and 6 years of age as of the date of written consent\n* Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product\n* Subjects or parent\u002Flegal representative willing to provide written informed consent and able to comply with the study requirements\n* Negative history of Varicella infection\n\nExclusion Criteria:\n\n* Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration of investigational drug\n* Subjects who have a history 2 times or more of varicella vaccine injections\n* Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product\n* Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product\n* Subjects with a history of Guillain-Barre syndrome.\n* Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion\n* Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)\n* Active tuberculosis patient\n* Subjects who had received other vaccinations within 4 weeks before the administration of investigational product\n* Subjects with immunodeficiency history\n* Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug\n* Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug\n* Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug\n* A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.\n* B. Subjects who administered high dose of corticosteroids (greater than 2 mg\u002Fkg\u002Fday in case of under 10kg subjects or ≥20mg\u002Fday in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical corticosteroids administration in allowed)\n* Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug\n* Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product\n* Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study",true,"ALL","4 Years","6 Years",{"count":71,"type":72},230,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","* Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination\n* Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination",[78],"Varicella","2024-01-23",{"date":81,"type":82},"2024-01-24","ACTUAL",{"date":84,"type":82},"2022-07-05",{"date":86,"type":72},"2027-06",{"name":88,"class":6},"Green Cross Corporation",1]