NCT00550745已完成4 期
A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11,999
- 主要终点
- Serious Adverse Events Reported Within 42 Days Postvaccination
研究概览
简要总结
The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •60+ years of Age
- •Signed an informed consent prior to the start of study
- •Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
- •Females must be postmenopausal or have a negative pregnancy test
排除标准
- •A history of allergic reaction to any vaccine component (including gelatin or neomycin)
- •Prior receipt of any varicella or zoster vaccine
- •Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
- •Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
- •Subject is pregnant or breastfeeding
- •Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
- •An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
- •Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
- •Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
- •Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
研究组 & 干预措施
1
Experimental
Arm 1: vaccine
干预措施: Zoster Vaccine, Live (Biological)
2
Placebo Comparator
Arm 2: Placebo Comparator
干预措施: Comparator: placebo (Biological)
结局指标
主要结局
Serious Adverse Events Reported Within 42 Days Postvaccination
时间窗: 42 Days
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
次要结局
- Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination(6 months)
研究者
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