SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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