NCT00534248已完成3 期
A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22,439
- 主要终点
- Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
研究概览
简要总结
This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between 50 - 59 years of age
- •No fever on day of vaccination
- •Females of reproductive potential must be willing to use acceptable form of birth control
排除标准
- •Have received chicken pox or shingles vaccine
- •Have already had shingles
- •Have recently had another vaccination
- •Pregnant or breast feeding. Have participated in another research study in the last 30 days
- •You are taking certain antiviral drugs
- •History of allergic reaction to any vaccine component, including gelatin or neomycin
研究组 & 干预措施
Zostavax™
Experimental
Participants randomized to receive Zoster Vaccine, Live (Zostavax™).
干预措施: Zoster Vaccine, Live (Zostavax™) (Biological)
Placebo
Placebo Comparator
Participants randomized to receive Placebo.
干预措施: Comparator: Placebo (Biological)
结局指标
主要结局
Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
时间窗: 2 Years
Incidence rate of HZ cases was defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. Vaccine efficacy for HZ was defined as the relative reduction in incidence rate of HZ in the group that received Zostavax™ compared with the group that received placebo based on the intent-to-treat population.
次要结局
- Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group(6 Weeks)
- Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period(Through 42 days post-vaccination)
研究者
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