RecruitingPhase 3NCT07054099

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


Sponsor

GC Biopharma Corp

Enrollment

474 participants

Start Date

Mar 17, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 MonthsMax Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called MG1111 (Barycela inj.) and a biological treatment called VARIVAX™ for people with chickenpox vaccine and varicella (chickenpox). The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Months to 12 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMG1111 (Barycela inj.)

MG1111 (Barycela inj.)

BIOLOGICALVARIVAX™

Varivax™


Locations(1)

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

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NCT07054099


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