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

Not Applicable

Not yet recruiting

• Conditions: Varicella (Chickenpox); Chickenpox Vaccine
• Interventions: Biological: MG1111 (Barycela inj.); Biological: VARIVAX™

• Registration Number: NCT07054099
• Lead Sponsor: GC Biopharma Corp

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Study First Posted: 2025-07-08
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11
• Study Start: 2026-03-01
• Primary Completion: 2027-08
• Study Completion: 2036-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 474

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MG1111 (Barycela inj.)	MG1111 (Barycela inj.)	-
Varivax™	VARIVAX™	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants who achieved seroconversion at 42 days after second vaccination	42 days after second vaccination

Secondary Outcome Measures

Name	Time	Method
Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX	7 days after each vaccination
Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX	42 days after each vaccination
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX	6 months after second vaccination