[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Green Cross Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"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",[28],"Varicella","RECRUITING","2024-01-23",{"date":32,"type":33},"2024-01-24","ACTUAL",{"date":35,"type":33},"2022-07-05",{"date":37,"type":22},"2027-06",{"name":39,"class":40},"Green Cross Corporation","INDUSTRY",""]