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

Launched by GC BIOPHARMA CORP · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new chickenpox vaccine called MG1111 (BARYCELA Inj.) to see if it works as well and is as safe as the current vaccine called VARIVAX. The study will include healthy children between the ages of 1 year and 12 years. Researchers want to understand how children’s immune systems respond to MG1111 after two doses and monitor their health for 42 days, with follow-up visits for up to 10 years to check if they get chickenpox.

To join this study, children must be healthy and have never had chickenpox or received any chickenpox vaccine before. They also should not have been around anyone with chickenpox in the last month or have any serious illness or allergy symptoms before getting the vaccine. If eligible, participants will receive two doses of the vaccine and be closely monitored to make sure the vaccine is safe and effective. This study is not yet recruiting participants but will take place at multiple locations in different countries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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