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NOT YET RECRUITING
NCT07054099
PHASE3

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

Sponsor: GC Biopharma Corp

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 12 Years

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2026-03

Completion Date

2036-07

Last Updated

2025-07-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

MG1111 (Barycela inj.)

MG1111 (Barycela inj.)

BIOLOGICAL

VARIVAX™

Varivax™