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
1 other identifier
interventional
474
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2025
CompletedFirst Posted
Study publicly available on registry
July 8, 2025
CompletedStudy Start
First participant enrolled
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2036
April 17, 2026
April 1, 2026
1.4 years
July 7, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants who achieved seroconversion at 42 days after second vaccination
42 days after second vaccination
Secondary Outcomes (3)
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
Study Arms (2)
MG1111 (Barycela inj.)
EXPERIMENTALVarivax™
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2025
First Posted
July 8, 2025
Study Start
March 17, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
July 1, 2036
Last Updated
April 17, 2026
Record last verified: 2026-04