MG1111 (BARYCELA) versus VARIVAX for preventing chickenpox in children 1 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
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 |
| Enrollment | 474 (estimated) |
| Ages | 12 Months to 12 Years |
| Sex | All |
| Sponsor | GC Biopharma Corp Industry-sponsored |
| Locations | 1 site (Khon Kaen, Changwat Khon Kaen) |
| Trial ID | NCT07054099 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
Why it matters
Potential benefit: If successful, MG1111 could provide an effective alternative varicella vaccine option for young children.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Khon Kaen, Changwat Khon Kaen
- Srinagarind Hospital — Khon Kaen, Changwat Khon Kaen, Thailand (Recruiting)
Study contacts
- Study coordinator: Minji Ko
- Email: mg1111d@gccorp.com
- Phone: +82-31-260-9143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.