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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. 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.
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
2026-07-04
Completion Date
2028-01-02
Last Updated
2026-09-15
Healthy Volunteers
Yes
Conditions
Interventions
NBP608 (Mid Potency)
NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
NBP608 (Low Potency)
NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
Varivax®
Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).
SKYVaricella®
SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).
Normal Saline (Placebo)
Placebo consisting of normal saline (0.9% sodium chloride solution).
Locations (14)
San Pedro Sula, site 101
San Pedro Sula, Cortés Department, Honduras
Tegucigalpa, site 102
Tegucigalpa, Francisco Morazán Department, Honduras
Manila, site 301
Manila, National Capital Region, Philippines
Quezon City, site 302
Quezon City, National Capital Region, Philippines
Quezon City, site 303
Quezon City, National Capital Region, Philippines
Daegu, site 404
Daegu, Daegu, South Korea
Ansan, site 401
Ansan, Gyeonggi-do, South Korea
Hwaseong-si, site 406
Hwaseong-si, Gyeonggi-do, South Korea
Seongnam-sit, site 405
Seongnam-si, Gyeonggi-do, South Korea
Incheon, site 403
Incheon, Incheon, South Korea
Seoul, site 402
Seoul, Seoul, South Korea
Seoul, site 408
Seoul, Seoul, South Korea
Seoul, site 407
Seoul, Seoul, South Korea
Khon Kaen City, site 201
Khon Kaen, Changwat Khon Kaen, Thailand