SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years

This is a Phase III, randomized, Double-blinded, Active-controlled, Multinational, Multicenter study designed to evaluate the safety and immunogenicity of a two-dose regimen of NBP608 in children aged 12 months to 12 years.

Approximately 780 participants will be enrolled in this multinational, multicenter, randomized study and assigned in a 4:4:4:1 ratio to four groups: two investigational vaccine groups (NBP608 mid-potency and low-potency) and two active control groups (licensed varicella vaccines, Varivax® and SKYVaricella®). Each of the NBP608 groups and Active Control Group 1 (Varivax®) will include approximately 240 participants, while Active Control Group 2 (SKYVaricella®) will include approximately 60 participants.

Within each group, participants will be further randomized in a 3:1 ratio to receive either two doses or one dose of the assigned study vaccine.

Immunogenicity will be assessed using blood samples collected at predefined time points to evaluate immune responses to varicella. Safety will be evaluated throughout the study by monitoring adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) following vaccination.

Each participant will take part in the study for approximately 15 months, including scheduled clinic visits and follow-up assessments. The overall study duration will depend on enrollment progress and completion of follow-up across all participating countries.