SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years
A Phase III, Randomized, Double-blinded, Active-controlled, Multinational, Multicenter Study to Assess the Safety and Immunogenicity of a Two-dose Regimen of SKYVaricella® (NBP608) in Children Aged 12 Months to 12 Years
SK Bioscience Co., Ltd.
780 participants
Jul 4, 2026
INTERVENTIONAL
Conditions
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. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Participants will: Receive two subcutaneous injections of a study vaccine administered. Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).
SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).
Placebo consisting of normal saline (0.9% sodium chloride solution).
Locations(14)
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For the most up-to-date information, visit the official listing.
NCT07415252