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
Recruiting
Phase 3
Interventional Study
Varicella (Chickenpox)
Chickenpox Vaccine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 12 Months – 12
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 474 (estimated)
- Sponsor
- GC Biopharma Corp · Industry
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About This Trial
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 Locations
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Eligibility 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 w…