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.
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
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
Parallel
MG1111 (Barycela inj.)
Biological/VaccineMG1111 (Barycela inj.)
VARIVAX™
Biological/VaccineVarivax™
Proportion of participants who achieved seroconversion at 42 days after second vaccination
Percentage of participants reporting local and systemic solicited adverse events during the first 7 days after each vaccination with MG1111 or VARIVAX
Percentage of participants reporting unsolicited adverse events during the first 42 days after each vaccination with MG1111 or VARIVAX
Percentage of participants reporting serious adverse events until 6 months after second vaccination with MG1111 or VARIVAX
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