drugset / Trial / NCT07415252

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

NCT07415252

Phase 3 Not yet recruiting 780 enrolled SK Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The goal of this study is to evaluate the safety and immunogenicity of an investigational varicella vaccine in children. Researchers will compare the investigational vaccine, NBP608, with licensed varicella vaccines. The study includes children aged 12 months to 12 years. Approximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group. Participants will: Receive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable). Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.

Timeline

Start
2026-06-05
Primary completion
2027-02-13
Completion
2028-01-02

Drugs

EvaluationDrugModalityDoseRoute
Subject NBP608 Vaccine 0.5 ml Subcutaneous
Subject SKYVaricella® Vaccine 0.5 ml Subcutaneous
Subject Varivax Vaccine 0.5 ml Subcutaneous

Indications