* 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
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
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
Parallel
MG1111 (BARICELA)
Biological/Vaccine0.5ml, single dose, subcutaneous injection
VARIVAX
Biological/Vaccine0.5ml, single dose, subcutaneous injection
Suduvax
Biological/Vaccine0.5ml, single dose, subcutaneous injection
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
Solicited local / systemic adverse events
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
Unsolicited adverse events
Unsolicited adverse events that occurred within 42 days after the IP administration
Vital signs (blood pressure, pulse rate, respiration rate and body temperature)
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.
Serious adverse events
Serious adverse events that occurred within 1 year after the IP administration
GMT and GMR of the antibody titer
GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration
GMV and GMR of VZV-CMI response
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
GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year
Varicella-like rash
Varicella-like rash occurred after IP administration for 3 years
Varicella-zoster virus genotyping
Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
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