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.
Approximately 780 participants will take part in this study. Participants will be randomly assigned to receive either the investigational vaccine (NBP608) or licensed varicella vaccines. Some participants will receive two doses, while others will receive one dose, according to the assigned study group.
Participants will:
Receive two subcutaneous injections of a study vaccine, administered approximately three months apart (if applicable).
Visit the study clinic seven times over approximately 15 months. Receive follow-up phone calls 7 days after each vaccination to monitor for safety.
Participant must be ≥12 months to ≤12 years of age, at the time of informed consent.
Participant is healthy or medically stable, as determined by the investigator through medical history, physical examination, and overall clinical assessment.
Participant's parents/LARs are able and willing to comply with all study procedures and attend all scheduled visits.
Female participants of childbearing potential (i.e., post-menarcheal females) must agree to maintain complete sexual abstinence from heterosexual intercourse, from at least 4 weeks prior to the first study vaccination and through 12 weeks following the second study vaccination (Visit 5).
Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile illness (tympanic temperature >38°C), or acute illness within 24 hours prior to any study vaccination (Participant may be enrolled 24 hours after resolution of these symptoms).
History of suspected or laboratory-confirmed VZV infection
Close contact or household exposure to an individual with suspected or laboratory-confirmed VZV infection within 4 weeks prior to the first study vaccination.
Immunocompromised individuals
Parallel
NBP608 (Mid Potency)
Biological/VaccineNBP608 (mid potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
NBP608 (Low Potency)
Biological/VaccineNBP608 (low potency) is a live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
Varivax®
Biological/VaccineVarivax® is a licensed live attenuated varicella virus vaccine (Oka/Merck strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥1,350 PFU after reconstitution.
SKYVaricella®
Biological/VaccineSKYVaricella® is a licensed live attenuated varicella virus vaccine (Oka/SK strain). It is supplied as a lyophilized single-dose vial with a separate diluent and administered as a 0.5 mL subcutaneous injection. Each dose contains ≥2,400 PFU after reconstitution.
Normal Saline (Placebo)
Other interventionPlacebo consisting of normal saline (0.9% sodium chloride solution), administered as a 0.5 mL subcutaneous injection.
Difference in FAMA Assay-Measured Varicella-Zoster Virus (VZV) Seroconversion Rate 6 Weeks After the First Dose
FAMA seroconversion rate will be assessed using the fluorescent antibody to membrane antigen (FAMA) assay to measure varicella-zoster virus (VZV) IgG antibodies and will be compared between the investigational vaccine (NBP608) and a licensed varicella vaccine (Varivax®) 6 weeks after the first dose. The FAMA seroconversion rate is defined as the proportion of participants who are seronegative at baseline (antibody titer \<1:4) and achieve a VZV IgG antibody titer ≥1:4 at the post-vaccination visit.
Difference in FAMA Assay-Measured Varicella-Zoster Virus (VZV) Seroconversion Rate 6 Weeks After the Second Dose
FAMA seroconversion rate will be assessed using the fluorescent antibody to membrane antigen (FAMA) assay to measure varicella-zoster virus (VZV) IgG antibodies and will be compared between the investigational vaccine (NBP608) and a licensed varicella vaccine (Varivax®) 6 weeks after the second dose. The FAMA seroconversion rate is defined as the proportion of participants who are seronegative at baseline (antibody titer \<1:4) and achieve a VZV IgG antibody titer ≥1:4 at the post-vaccination visit.
Ratio of gpELISA Geometric Mean Titers 6 Weeks After the Second Dose
gpELISA geometric mean titers will be compared between the investigational vaccine (NBP608) and a licensed varicella vaccine(Varivax®) 6 weeks after the second dose.
FAMA Seroconversion Rates
Proportion of participants who are seronegative prior to vaccination, defined as having a pre-vaccination VZV IgG antibody titer less than 1:4, and who achieve post-vaccination FAMA VZV IgG antibody titers of at least 1:4, at least 1:16, and at least 1:64 at each specified assessment time point.
gpELISA Seroconversion Rates
Proportion of participants who are seronegative prior to vaccination, defined as having a pre-vaccination VZV IgG antibody concentration less than 50 mIU per milliliter, and who achieve post-vaccination VZV-specific IgG antibody concentrations of at least 50 mIU per milliliter at each specified assessment time point.
Geometric Mean Titers (GMTs)
VZV IgG antibodies measured by FAMA assay and gpELISA at each specified time point.
Geometric Mean Fold Rise (GMFR)
Fold increases in VZV IgG antibody titers measured by FAMA assay and gpELISA, calculated from the pre-vaccination baseline to each post vaccination time point.
Reverse cumulative distribution curves of VZV antibody titers
Reverse cumulative distribution curves of VZV antibody titers measured by FAMA and gpELISA at 6 weeks after each study vaccination
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