* 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
1. 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 2. 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 3. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
230
0.5ml, single dose, subcutaneous injection
0.5ml, single dose, subcutaneous injection
0.5ml, single dose, subcutaneous injection
Korea University Ansan Hospital
Ansan, South Korea
RECRUITINGIncidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
Time frame: within 7 days
Solicited local / systemic adverse events
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
Time frame: within 7 days
Unsolicited adverse events
Unsolicited adverse events that occurred within 42 days after the IP administration
Time frame: within 42 days
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.
Time frame: within 42 days
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
Time frame: within 42days
Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)
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.
Time frame: within 42 days
Serious adverse events
Serious adverse events that occurred within 1 year after the IP administration
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Time frame: within 1 year
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
Time frame: at Day1, Day42