Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-27 @ 10:33 PM
Study NCT ID:
NCT05422508
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2022-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After the Protocol v4.1 was approved by Ministry of Food and Drug Safety (02Jun2023), Subject eligibility was change to 4 \\~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination instead of 1st SUDUVAX inj. and Active Comparator: VARIVAX arm was deleted.\n\n\\*VARIVAX release has been discontinued.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2022-05-24', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'GMV and GMR of VZV-CMI response', 'timeFrame': 'at Day1, Day42', 'description': 'GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration'}, {'measure': 'GMT and GMR of the antibody titer', 'timeFrame': 'at Year1, Year2, Year3', 'description': 'GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year'}, {'measure': 'Varicella-like rash', 'timeFrame': 'anytime within 3 years (if applicable)', 'description': 'Varicella-like rash occurred after IP administration for 3 years'}, {'measure': 'Varicella-zoster virus genotyping', 'timeFrame': 'anytime within 3 years (if applicable)', 'description': 'Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years'}], 'primaryOutcomes': [{'measure': 'Incidence of fever (temperature ≥39.0℃)', 'timeFrame': 'within 7 days', 'description': 'Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration'}, {'measure': 'Solicited local / systemic adverse events', 'timeFrame': 'within 7 days', 'description': 'Solicited local / systemic adverse events that occurred within 7 days after the IP administration'}, {'measure': 'Unsolicited adverse events', 'timeFrame': 'within 42 days', 'description': 'Unsolicited adverse events that occurred within 42 days after the IP administration'}, {'measure': 'Vital signs (blood pressure, pulse rate, respiration rate and body temperature)', 'timeFrame': 'within 42 days', 'description': 'descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group.'}, {'measure': 'Incidence of fever (temperature ≥39.0℃)', 'timeFrame': 'within 42days', 'description': 'Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration'}, {'measure': 'Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)', 'timeFrame': 'within 42 days', 'description': "the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table."}], 'secondaryOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': 'within 1 year', 'description': 'Serious adverse events that occurred within 1 year after the IP administration'}, {'measure': 'GMT and GMR of the antibody titer', 'timeFrame': 'at Day1, Day42', 'description': 'GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicella']}, 'descriptionModule': {'briefSummary': '* 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', 'detailedDescription': '1. Safety\n\n * Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration\n * Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration\n * Solicited local/systemic AEs occurred within 7 days after the IP administration\n * Unsolicited adverse events that occurred within 42 days after the IP administration\n * Serious adverse events that occurred within 1 year after the IP administration\n * Vital signs and physical examinations\n2. Efficacy (Immunogenicity)\n\n -GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration\n3. Exploratory assessment\n\n * GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration\n * GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years\n * Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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/legal 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/kg/day in case of under 10kg subjects or ≥20mg/day 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"}, 'identificationModule': {'nctId': 'NCT05422508', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'GC Biopharma Corp'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MG1111_VAR_P0201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MG1111(BARICELA) arm', 'description': '0.5ml, single dose, subcutaneous injection', 'interventionNames': ['Biological: MG1111 (BARICELA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VARIVAX arm', 'description': '0.5ml, single dose, subcutaneous injection', 'interventionNames': ['Biological: VARIVAX']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suduvax arm', 'description': '0.5ml, single dose, subcutaneous injection', 'interventionNames': ['Biological: Suduvax']}], 'interventions': [{'name': 'MG1111 (BARICELA)', 'type': 'BIOLOGICAL', 'description': '0.5ml, single dose, subcutaneous injection', 'armGroupLabels': ['MG1111(BARICELA) arm']}, {'name': 'VARIVAX', 'type': 'BIOLOGICAL', 'description': '0.5ml, single dose, subcutaneous injection', 'armGroupLabels': ['VARIVAX arm']}, {'name': 'Suduvax', 'type': 'BIOLOGICAL', 'description': '0.5ml, single dose, subcutaneous injection', 'armGroupLabels': ['Suduvax arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ansan', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}], 'centralContacts': [{'name': 'Hye Won Shin', 'role': 'CONTACT', 'email': 'hwshin27@gccorp.com', 'phone': '+82-31-260-9032'}], 'overallOfficials': [{'name': 'Yun-kyung Kim, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Ansan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}