A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
研究概览
简要总结
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
排除标准
- •History of allergy to any vaccine component
- •Prior receipt of a varicella or zoster vaccine
- •Ability to defend against infection is suppressed by a medical condition or medication
研究组 & 干预措施
Placebo / ZOSTAVAX™
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
干预措施: Comparator: Placebo (Biological)
ZOSTAVAX™ / Placebo
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
干预措施: zoster vaccine live (ZOSTAVAX™) (Biological)
ZOSTAVAX™ / Placebo
Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2)
干预措施: Comparator: Placebo (Biological)
Placebo / ZOSTAVAX™
Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2)
干预措施: zoster vaccine live (ZOSTAVAX™) (Biological)
结局指标
主要结局
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
时间窗: To Day 28 postvaccination
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
次要结局
- Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination(4 weeks postvaccination)
- Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination(From prevaccination (baseline) to 4 weeks postvaccination)