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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 780
- 试验地点
- 14
- 主要终点
- Seroconversion rate of varicella-zoster virus(VZV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 must agree to comply with applicable contraceptive requirements as defined in the protocol.
- •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.
- •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.
排除标准
- •1. Participants with any acute illness, including fever or clinically significant symptoms, at the time of study vaccination.
- •History of varicella-zoster virus (VZV) infection or recent exposure to VZV.
- •3. Presence of household contacts at high risk for severe VZV infection
- •History of immunodeficiency, autoimmune disease, or other conditions affecting the immune system.
- •5. History of bleeding disorders contraindicating vaccination.
- •History of severe allergic reactions to vaccines or vaccine components.
- •History of Guillain-Barré syndrome associated with prior vaccination.
- •Active untreated tuberculosis infection.
- •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.
- •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.
研究组 & 干预措施
Test group 2: NBP608 (Low Potency)
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: Normal Saline (Placebo) (Other)
Active control group 1: Varivax®
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: Varivax® (Biological)
Active control group 1: Varivax®
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: Normal Saline (Placebo) (Other)
Active control group 2: SKYVaricella®
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: SKYVaricella® (Biological)
Active control group 2: SKYVaricella®
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: Normal Saline (Placebo) (Other)
Test group 1: NBP608 (Mid Potency)
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: NBP608 (Mid Potency) (Biological)
Test group 1: NBP608 (Mid Potency)
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: Normal Saline (Placebo) (Other)
Test group 2: NBP608 (Low Potency)
Participants receive either a one-dose regimen or a two-dose regimen consisting of two subcutaneous injections administered.
干预措施: NBP608 (Low Potency) (Biological)
结局指标
主要结局
Seroconversion rate of varicella-zoster virus(VZV)
时间窗: 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
时间窗: 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
Difference in FAMA Assay-Measured Varicella-Zoster Virus (VZV) Seroconversion Rate 6 Weeks After the First Dose
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Seroconversion Rates(Time Frame: 6 weeks after each vaccination, 6 months after the second vaccination)
- Geometric Mean Titers (GMTs)(6 weeks after each vaccination, 6 months after the second vaccination)
- Geometric Mean Fold Rise (GMFR)(from baseline to each post-vaccination timepoint)
- Geometric Mean Fold Reduction (GMFRd)(from baseline to each post-vaccination timepoint)
- Immediate reactions(Within 30 minutes)
- Solicited adverse events(Within 14 days)
- Unsolicited adverse events(Within 42 days)
- Serious adverse events, medically attended AEs, and AEs leading to withdrawal(during study period)
- Adverse events of special interest(during the study period)
- FAMA Seroconversion Rates(Baseline; 6 weeks and 3 months after the first vaccination; and 6 weeks, 6 months, and 12 months after the second vaccination)
- gpELISA Seroconversion Rates(Baseline; 6 weeks and 3 months after the first vaccination; and 6 weeks, 6 months, and 12 months after the second vaccination)
- Geometric Mean Titers (GMTs)(Baseline; 6 weeks and 3 months after the first vaccination; and 6 weeks, 6 months, and 12 months after the second vaccination)
- Geometric Mean Fold Rise (GMFR)(From pre-vaccination baseline to 12 months after the second dose (assessed at 6 weeks and 3 months after the first dose and at 6 weeks, 6 months, and 12 months after the second dose))
- Geometric Mean Fold Reduction (GMFRd)(From persistence baseline (defined as the peak antibody titer observed post-dose 2) up to 12 months after the second dose (assessed at 6 months and 12 months after the second dose))
- Immediate reactions within 30 minutes after vaccination(Within 30 minutes after each vaccination (Visit 2 and Visit 5))
- Solicited local adverse events within 7 days after vaccination(Within 7 days after each vaccination (Visit 2 and Visit 5))
- Solicited systemic adverse events within 14 days after vaccination(Within 14 days after each vaccination (Visit 2 and Visit 5))
- Unsolicited adverse events within 42 days after vaccination(Within 42 days after each vaccination (Visit 2 and Visit 5))
- Serious adverse events, medically attended AEs, and AEs leading to withdrawal(From the first vaccination until study completion (approximately 12 months after the second vaccination))
- Adverse events of special interest(From the first vaccination until study completion (approximately 12 months after the second vaccination))