NCT05422508

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

* 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

Detailed description

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

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	MG1111 (BARICELA)	0.5ml, single dose, subcutaneous injection
BIOLOGICAL	VARIVAX	0.5ml, single dose, subcutaneous injection
BIOLOGICAL	Suduvax	0.5ml, single dose, subcutaneous injection

Timeline

• Start date: 2022-07-05
• Primary completion: 2025-06-01
• Completion: 2027-06-01
• First posted: 2022-06-16
• Last updated: 2024-01-24

Locations

1 site across 1 country: South Korea