NCT07054099

A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years

A Phase III, Double-blind, Randomized, Multicenter, Multinational, Active-controlled, Non-inferiority Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Sponsor: GC Biopharma Corp · Industry
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Accepted

Summary

This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.

Conditions

• Varicella (Chickenpox)
• Chickenpox Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MG1111 (Barycela inj.)	MG1111 (Barycela inj.)
BIOLOGICAL	VARIVAX™	Varivax™

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-08-01
• Completion: 2036-07-01
• First posted: 2025-07-08
• Last updated: 2026-04-17

Locations

1 site across 1 country: Thailand