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
GC Biopharma Corp
474 participants
Mar 17, 2026
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
Inclusion Criteria2
- Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent.
- Participant is overtly healthy as determined by the investigator
Exclusion Criteria4
- Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening
- Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV
- Participants with acute moderate or severe infection with or without fever at the time of dosing
- Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
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Interventions
MG1111 (Barycela inj.)
Varivax™
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07054099