Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
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:
-
Written informed consent provided by the participant
-
Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
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Willing to receive influenza vaccination
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Older cohort has received their influenza vaccine for the previous influenza season
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Exclusion Criteria:
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Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily)
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Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
-
Participant has received a community available influenza vaccine for the approaching influenza season
-
Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)
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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：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Flu Vaccine SD
Fluzone Standard Dose Influenza Vaccine |
其他名称：
|
|
有源比较器：Flu Vaccine HD
Fluzone High Dose Influenza Vaccine |
其他名称：
|
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 |
|---|---|---|
|
Number of Influenza Cases
大体时间：five years
|
Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (> 99°F or 37.3°C orally or 100°F rectally) [41]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season. |
five years
|
合作者和调查者
合作者
调查人员
- 首席研究员：Janet E McElhaney, MD、Health Sciences North Research Institute
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 (实际的)
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 (估计的)
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
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.