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.
This is a Phase III, randomized, Double-blinded, Active-controlled, Multinational, Multicenter study designed to evaluate the safety and immunogenicity of a two-dose regimen of NBP608 in children aged 12 months to 12 years. Immunogenicity will be assessed using blood samples collected at predefined time points to evaluate immune responses to varicella. Safety will be evaluated throughout the study by monitoring adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) following vaccination. Each participant will take part in the study for approximately 15 months, including scheduled clinic visits and follow-up assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
780
NBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
NBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain).
Varivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain).
SKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain).
Placebo consisting of normal saline (0.9% sodium chloride solution).
San Pedro Sula, site 101
San Pedro Sula, Cortés Department, Honduras
NOT_YET_RECRUITINGTegucigalpa, site 102
Tegucigalpa, Francisco Morazán Department, Honduras
RECRUITINGManila, site 301
Manila, National Capital Region, Philippines
RECRUITINGQuezon City, site 302
Quezon City, National Capital Region, Philippines
RECRUITINGQuezon City, site 303
Quezon City, National Capital Region, Philippines
RECRUITINGDaegu, site 404
Daegu, Daegu, South Korea
RECRUITINGAnsan, site 401
Ansan, Gyeonggi-do, South Korea
RECRUITINGHwaseong-si, site 406
Hwaseong-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGSeongnam-sit, site 405
Seongnam-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGIncheon, site 403
Incheon, Incheon, South Korea
RECRUITING...and 4 more locations
Seroconversion rate of varicella-zoster virus(VZV)
Seroconversion rate of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after each vaccination
Time frame: 6 weeks after each dose.
Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies
Geometric mean antibody titer (GMT) of varicella-zoster virus(VZV) IgG antibodies at 6 weeks after the second vaccination
Time frame: 6 weeks after the second dose.
Seroconversion Rates
Proportion of participants who are seronegative prior to vaccination at each specified assessment time point.
Time frame: Time Frame: 6 weeks after each vaccination, 6 months after the second vaccination
Geometric Mean Titers (GMTs)
VZV IgG antibodies at each specified time point.
Time frame: 6 weeks after each vaccination, 6 months after the second vaccination
Geometric Mean Fold Rise (GMFR)
Fold increases in VZV IgG antibody titers
Time frame: from baseline to each post-vaccination timepoint
Geometric Mean Fold Reduction (GMFRd)
Fold reductions in VZV IgG antibody titers
Time frame: from baseline to each post-vaccination timepoint
Immediate reactions
Percentage of participants reporting any immediate reactions following each vaccination.
Time frame: Within 30 minutes
Solicited adverse events
Percentage of participants reporting solicited adverse events following each vaccination.
Time frame: Within 14 days
Unsolicited adverse events
Percentage of participants experiencing any unsolicited adverse events following each vaccination.
Time frame: Within 42 days
Serious adverse events, medically attended AEs, and AEs leading to withdrawal
Percentage of participants experiencing any serious adverse events, medically attended adverse events, or adverse events leading to withdrawal during the study period.
Time frame: during study period
Adverse events of special interest
Percentage of participants experiencing any adverse events of special interest during the study period.
Time frame: during the study period
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