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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
2026-06-15
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.
Locations (15)
DEMEDICA
San Pedro Sula, Cortés Department, Honduras
Centhicsa
Tegucigalpa, Francisco Morazán Department, Honduras
Manila Doctors Hospital
Manila, National Capital Region, Philippines
UERM
Quezon City, National Capital Region, Philippines
Feu-Nrmf Clinical Research Unit
Quezon City, National Capital Region, Philippines
Keimyung University Dongsan Hospital
Daegu, Daegu, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, Incheon, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand