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

Varicella Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

• NCT number: NCT05422508
• Study type: Interventional
• Source: GC Biopharma Corp
• Contact: Hye Won Shin
• Phone: +82-31-260-9032
• Email: hwshin27@gccorp.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 5, 2022
• Completion date: June 2027