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

MG1111_VAR_P0201

* Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination * Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination

2022-07-05

2025-06-01

2027-06-01

Recruiting

Early phase I

230

Inclusion Criteria: * Healthy children between 4 and 6 years of age as of the date of written consent * Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product * Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements * Negative history of Varicella infection Exclusion Criteria: * 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 * Subjects who have a history 2 times or more of varicella vaccine injections * Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product * Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product * Subjects with a history of Guillain-Barre syndrome. * Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion * Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin) * Active tuberculosis patient * Subjects who had received other vaccinations within 4 weeks before the administration of investigational product * Subjects with immunodeficiency history * Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug * Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug * Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug * A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc. * 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) * Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug * Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product * Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', '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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 230, 'type': 'ESTIMATED'}}

2024-01-24