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Recruiting Phase 3 NCT07054099

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

Phase 3 – large-scale trial before approval
Conditions: Varicella (Chickenpox) Chickenpox Vaccine

Sponsor: GC Biopharma Corp

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
MG1111 (Barycela inj.)
BIOLOGICAL
VARIVAX™
BIOLOGICAL
Locations 1
Thailand (1)
Srinagarind Hospital
Khon Kaen , Changwat Khon Kaen
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Months
Maximum age
12 Years
Healthy volunteers
No
Start date
17.03.2026
Completion date
01.07.2036
Registry ID
NCT07054099
Source
clinicaltrials.gov
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