ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1
Arm 1: vaccine
|
single 0.65 mL Zoster Vaccine, Live injection.
6 month treatment period.
|
安慰剂比较:2
Arm 2: Placebo Comparator
|
single 0.65 mL Placebo injection.
6 month treatment period.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serious Adverse Events Reported Within 42 Days Postvaccination
大体时间: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. |
42 Days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
大体时间:6 months
|
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. |
6 months
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Zoster Vaccine, Live的临床试验
-
GlaxoSmithKline完全的带状疱疹美国, 澳大利亚, 德国, 西班牙, 日本, 台湾, 瑞典, 大韩民国, 香港, 墨西哥, 加拿大, 法国, 意大利, 巴西, 爱沙尼亚, 英国, 捷克语, 芬兰
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VA Office of Research and Development招聘中
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Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University 和其他合作者主动,不招人
-
SENAI CIMATEC招聘中
-
Johns Hopkins UniversityCenters for Disease Control and Prevention完全的
-
University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
-
Louise ReaganAmerican Diabetes Association招聘中