MG1111 (BARYCELA) versus VARIVAX for preventing chickenpox in children 1 to 12 years
Official title: 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
Run by GC Biopharma Corp · NCT07054099 · Data updated 2026-11-12
This will test whether the MG1111 (BARYCELA) vaccine is safe and produces an immune response comparable to VARIVAX in healthy children aged 12 months to 12 years.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Months to 12 Years |
| Sex | All |
| Enrollment | 474 (estimated) |
| Sponsor | GC Biopharma Corp Industry-sponsored |
| Locations | 1 site (Khon Kaen, Changwat Khon Kaen) |
| Status | Recruiting |
| Started | March 17, 2026 |
| Main results expected | August 2027 |
| Study ends | July 2036 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07054099 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 12 months to 12 years with no history of varicella infection or prior varicella vaccination and without recent varicella exposure are ideal candidates.
✕Probably not a fit
Children with prior varicella infection or vaccination, recent known exposure to varicella, acute moderate or severe infection at dosing, or recent allergy symptoms are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares the safety and immunogenicity of the MG1111 (BARYCELA) vaccine with the licensed VARIVAX vaccine in healthy children aged 12 months to 12 years. Participants will receive two vaccine doses and be monitored for 42 days after the second dose for safety and immune response measurements. The study includes long-term surveillance for up to 10 years to record any varicella infections. The trial is sponsored by GC Biopharma Corp and conducted at Srinagarind Hospital in Khon Kaen, Thailand.
Why it matters
Potential benefit: If successful, MG1111 could provide an effective alternative varicella vaccine option for young children.
How similar studies have gone: Licensed varicella vaccines like VARIVAX have a long-established record of safety and effectiveness, while MG1111 is a newer vaccine formulation now being evaluated in a Phase 3 comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, Thailand Recruiting
Study contacts
- Study coordinator: Minji Ko
- Email: mg1111d@gccorp.com
- Phone: +82-31-260-9143
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.