Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-03-03 @ 8:15 AM
Study NCT ID:
NCT03375502
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MG1111 in Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D014611', 'term': 'Vaccination'}], 'ancestors': [{'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D016233', 'term': 'Immunotherapy, Active'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011322', 'term': 'Primary Prevention'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003140', 'term': 'Communicable Disease Control'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 814}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Local/systemic solicited AEs [Safety]', 'timeFrame': 'during the first 7 days after administration of IP'}, {'measure': 'Incidence of Unsolicited AEs [Safety]', 'timeFrame': 'Until Day 42 after administration of IP'}, {'measure': 'Incidence of Serious adverse events [Safety]', 'timeFrame': 'Until 6 months after administration of IP'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects who achieved seroconversion', 'timeFrame': '42 days after vaccination'}], 'secondaryOutcomes': [{'measure': 'Geometric mean titer(GMT) measured by the FAMA assay', 'timeFrame': 'At day 0 and Day 42 post-vaccination'}, {'measure': 'Geometric mean titer(GMT) measured by gpELISA', 'timeFrame': 'At day 0 and Day 42 post-vaccination'}]}, 'conditionsModule': {'conditions': ['Healthy Children']}, 'descriptionModule': {'briefSummary': 'To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children aged 12 months to 12 years.\n* Subjects or parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures\n* Negative history of Varicella and varicella vaccine\n* Subject in good health, based on medical history and physical examination\n\nExclusion Criteria:\n\n* Subjects who have a history of Varicella or administration of varicella vaccine\n* Subjects who have ahd an acute febrile episode at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.'}, 'identificationModule': {'nctId': 'NCT03375502', 'briefTitle': 'A Study of MG1111 in Healthy Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': 'A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children', 'orgStudyIdInfo': {'id': 'MG1111_P2/3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MG1111(Varicella vaccine)', 'description': 'A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1', 'interventionNames': ['Drug: Varicella Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator(Varicella vaccine)', 'description': 'A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1', 'interventionNames': ['Drug: Varicella Vaccine']}], 'interventions': [{'name': 'Varicella Vaccine', 'type': 'DRUG', 'otherNames': ['vaccination'], 'description': 'The subject will receive investigational product or comparator.', 'armGroupLabels': ['Comparator(Varicella vaccine)', 'MG1111(Varicella vaccine)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banpo-dong', 'state': 'Seoul', 'country': 'South Korea', 'facility': "The catholic university of Korea, Seoul st. mary's hospital", 'geoPoint': {'lat': 37.49528, 'lon': 126.99361}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}