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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
* 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
Age
4 - 6 years
Sex
ALL
Healthy Volunteers
Yes
Korea University Ansan Hospital
Ansan, South Korea
Start Date
July 5, 2022
Primary Completion Date
June 1, 2025
Completion Date
June 1, 2027
Last Updated
January 24, 2024
230
ESTIMATED participants
MG1111 (BARICELA)
BIOLOGICAL
VARIVAX
BIOLOGICAL
Suduvax
BIOLOGICAL
Lead Sponsor
Green Cross Corporation
NCT07475000
NCT05095701
Data Source & Attribution
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