Ireland
--:--IST
Recruiting Phase 3

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

NCT07415252 · tracked via the Priya Life Science South Korea tracker
Sponsor
SK Bioscience Co., Ltd
Phase
Phase 3
Started
2026-07-04
Last updated
2026-09-15

Condition(s) studied

Varicella (Chickenpox)

Investigational drug(s) / intervention(s)

NBP608 (Mid Potency)NBP608 (Low Potency)Varivax® →SKYVaricella®Normal Saline (Placebo)

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).

Study 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

Sex
ALL
Min age
12 Months
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participant must be ≥12 months to ≤12 years of age, at the time of informed consent. 2. Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment. 3. Participant's parents/LARs are able and willing to comply with all study procedures and attend all scheduled visits. 4. Female participants of childbearing potential must agree to comply with applicable contraceptive requirements as defined in the protocol. 5. Female participants of a childbearing potential must have a negative urine pregnancy test at screening; pregnancy testing is not required for those not of childbearing potential. 6. Participant's parents/LARs are capable of providing signed informed consent, including agreement to comply with the requirements and restrictions specified in this protocol and in the informed consent form (ICF), before initiation of any study-specific procedures. Where applicable, the participant must also be able to provide written assent in accordance with local regulations and IRB/IEC requirements. Exclusion Criteria: 1\. Participants with any acute illness, including fever or clinically significant symptoms, at the time of study vaccination. 2. History of varicella-zoster virus (VZV) infection or recent exposure to VZV. 3\. Presence of household contacts at high risk for severe VZV infection 4. History of immunodeficiency, autoimmune disease, or other conditions affecting the immune system. 5\. History of bleeding disorders contraindicating vaccination. 6. History of severe allergic reactions to vaccines or vaccine components. 7. History of Guillain-Barré syndrome associated with prior vaccination. 8. Active untreated tuberculosis infection. 9. Any significant medical condition that, in the investigator's judgment, may interfere with study participation or interpretation of results. 10\. Prior receipt of any varicella-containing vaccine. 11. Receipt or planned use of vaccines, medications, immunoglobulins, blood products, or immunosuppressive therapies that may interfere with study evaluation, as defined in the protocol. 12\. Participation in another clinical study involving an investigational intervention within a protocol-defined timeframe. 13\. Study staff, investigators, and their immediate family members.

Primary outcome measure(s)

  • Seroconversion rate of varicella-zoster virus(VZV) — 6 weeks after each dose.
    Seroconversion rate of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after each vaccination
  • Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies — 6 weeks after the second dose.
    Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after the second vaccination

Trial sites (14)

FacilityCityRegionStatus
San Pedro Sula, site 101 San Pedro Sula Cortés Department Not Yet Recruiting
Tegucigalpa, site 102 Tegucigalpa Francisco Morazán Department Recruiting
Manila, site 301 Manila National Capital Region Recruiting
Quezon City, site 302 Quezon City National Capital Region Recruiting
Quezon City, site 303 Quezon City National Capital Region Recruiting
Daegu, site 404 Daegu Daegu Recruiting
Ansan, site 401 Ansan Gyeonggi-do Recruiting
Hwaseong-si, site 406 Hwaseong-si Gyeonggi-do Not Yet Recruiting
Seongnam-sit, site 405 Seongnam-si Gyeonggi-do Not Yet Recruiting
Incheon, site 403 Incheon Incheon Recruiting
Seoul, site 402 Seoul Seoul Recruiting
Seoul, site 408 Seoul Seoul Not Yet Recruiting
Seoul, site 407 Seoul Seoul Not Yet Recruiting
Khon Kaen City, site 201 Khon Kaen Changwat Khon Kaen Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07415252 on ClinicalTrials.gov ↗ ← All trials in South Korea