A Randomized, Double Blinded, Multi-center Phase III Confirmatory Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 824
- 试验地点
- 2
- 主要终点
- GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
研究概览
简要总结
This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
详细描述
This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.
Total of five visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult over aged 50 years
- •Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent
排除标准
- •Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
- •Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
- •Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed)
- •Those who have previously received herpes zoster vaccine
- •Those who have a history of herpes zoster
- •Those with congenital or acquired immunodeficiency
- •Those with active untreated tuberculosis
- •Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination
- •Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study
结局指标
主要结局
GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
时间窗: 6 weeks after IP(Investigational Product) vaccination
The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA
时间窗: 6 weeks after IP(Investigational Product) vaccination
Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax
次要结局
- VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot)(6 weeks after IP(Investigational Product) vaccination)
- VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IL-2(Interleukin-2) ELISPOT (Enzyme-Linked Immunospot)(6 weeks after IP(Investigational Product) vaccination)