Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Chieti、意大利
- Dipartimento di Medicina e Scienze dell'Invecchiamento
-
Lanciano、意大利、66034
- Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37
-
-
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:
- 65 years of age or older
Exclusion Criteria:
- any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
- hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- known or suspected (or high risk of developing) impairment/alteration of immune function
- any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
- fever within the past 3 days
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：手臂 1
|
A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:
The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes. A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm. |
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 |
|---|---|---|
|
Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)
大体时间：21 days post-vaccination
|
The measures of immunogenicity for each antigen are:
|
21 days post-vaccination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).
大体时间：3 days, respectively 21 days post-vaccination
|
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |
3 days, respectively 21 days post-vaccination
|
合作者和调查者
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 (估计)
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.