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SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years
Sponsor: SK Bioscience Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Months - 12 Years
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2026-06-05
Completion Date
2028-01-02
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
NBP608 (Mid Potency)
NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
NBP608 (Low Potency)
NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
Varivax®
Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥1,350 PFU after reconstitution.
SKYVaricella®
SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
Normal Saline (Placebo)
Placebo consisting of normal saline (0.9% sodium chloride solution), administered as a 0.5 mL subcutaneous injection.