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RECRUITING
NCT07415252
PHASE3

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

Sponsor: SK Bioscience Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

NBP608 (Mid Potency)

NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).

BIOLOGICAL

NBP608 (Low Potency)

NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).

BIOLOGICAL

Varivax®

Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).

BIOLOGICAL

SKYVaricella®

SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).

OTHER

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