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
NCT07054099 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 474
Last updated 2026-04-17
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.
Conditions
- Varicella (Chickenpox)
- Chickenpox Vaccine
Interventions
- BIOLOGICAL
-
MG1111 (Barycela inj.)
MG1111 (Barycela inj.)
- BIOLOGICAL
-
VARIVAX™
Varivax™
Sponsors & Collaborators
-
GC Biopharma Corp
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Months
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-17
- Primary Completion
- 2027-08-31
- Completion
- 2036-07-31
Countries
- Thailand
Study Locations
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