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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

RecruitingPhase 2Ages 4 Years - 6 YearsAllGreen Cross Corporation
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In plain words

What the trial is, and whether it could suit you

* 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ„ƒ) 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 โ‰ฅ20mg/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
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What it tests

  • MG1111 (BARICELA)
  • VARIVAX
  • Suduvax
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Where

1 site
Korea University Ansan Hospital
Ansan, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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