Actively Recruiting
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
Led by GC Biopharma Corp · Updated on 2026-04-17
474
Participants Needed
1
Research Sites
537 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, Thailand, 40002
Actively Recruiting
Research Team
M
Minji Ko
CONTACT
S
Sujin Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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