An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
研究概览
简要总结
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •No fever on day of vaccination
- •Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- •Underlying chronic illness must be stable
排除标准
- •History of hypersensitivity reaction to any vaccine component
- •Prior history of herpes zoster
- •Prior receipt of varicella or zoster vaccine
- •Pregnant or breastfeeding
- •Have recently received immunoglobulins or blood products other than autologous blood transfusion
- •Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study
- •Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study
- •Use of immunosuppressive therapy
- •Known or suspected immune dysfunction
- •Use of nontopical antiviral therapy with activity against herpes virus
- •Known or suspected active untreated tuberculosis
结局指标
主要结局
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
时间窗: Day 1 (Baseline) and Week 4 postvaccination
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).
Geometric Mean Titer (GMT) of VZV Antibody
时间窗: Day 1 (Baseline) and 4 weeks postvaccination
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Percentage of Participants With Clinical Adverse Experiences
时间窗: Up to 42 days postvaccination
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
时间窗: Up to 42 days postvaccination
次要结局
未报告次要终点