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

• Safety

• Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
• Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
• Solicited local/systemic AEs occurred within 7 days after the IP administration
• Unsolicited adverse events that occurred within 42 days after the IP administration
• Serious adverse events that occurred within 1 year after the IP administration
• Vital signs and physical examinations
• Efficacy (Immunogenicity)

-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

• Exploratory assessment

• GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
• GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
• Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years

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