2010/2011 Trivalent Influenza Vaccination
2011年2月23日 更新者：The University of Hong Kong
Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device
Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.
研究概览
地位
完全的
条件
详细说明
This is a prospective, randomized, single centre trial in the Queen Mary Hospital.
We aim to recruit 400 subjects [with a minimum of 50 subjects per group] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for 2010/2011 TIV.
These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness (or healthcare workers).
Subjects will be randomly assigned into 4 groups: Group 1 (ID1) to receive a single low-dose intradermal injection of 2010/2011 TIV, with a microneedle device.
Group 2 (ID2) to receive a single higher low-dose intradermal injection of 2010/2011 TIV with a microneedle device.
Group 3 (IM15) to receive a single full-dose (15ug) standard 2010/2011 TIV delivered intramuscularly by conventional needle.
Group 4 (INT) to receive a single low-dose intradermal injection of 2010/2011 TIV, with Intanza® needle.
The 2010/2011 TIV used will be Fluzone®, Sanofi-Pasteur for group 3 and Intanza®, Sanofi-Pasteur for group 1,2 and 4.
研究类型
介入性
注册 (实际的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Hong Kong
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Hong Kong、Hong Kong、中国
- The University of Hong Kong, Queen Mary Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- All participants qualified for the HA/ CHP Mass Vaccination Program for TIV 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure.
- All patients give written informed consent.
- Subjects must be available to complete the study and comply with study procedures.
Exclusion Criteria:
- Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
- Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.
- Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis and cirrhosis.
- History of progressive or severe neurological disorders or Guillain-Barré Syndrome.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：IM15
15 mcg TIV 2010/2011 influenza vaccine delivered via intramuscular injection (control)
|
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
|
|
有源比较器：ID1
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)
|
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
|
|
有源比较器：ID2
Higher low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection (MicronJet)
|
TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
|
|
有源比较器：INT
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device
|
Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental
|
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 |
|---|---|---|
|
seroconversion rate
大体时间：day 21
|
Seroconversion rate (percentage of subjects with a fourfold increase in antibody titres, providing a minimal post vacination titre of 1:40) on day 21 by TIV 2010/2011 hemagglutination inhibition (HI) between the ID and IM groups
|
day 21
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse events
大体时间：30 minutes post vaccination
|
Adverse events secondary to vaccination with different devices
|
30 minutes post vaccination
|
|
Seroprotection rate
大体时间：Day 21
|
percentage of subjects with a post vaccination titre of at least 1:40
|
Day 21
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年11月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2011年2月1日
研究注册日期
首次提交
2011年2月23日
首先提交符合 QC 标准的
2011年2月23日
首次发布 (估计)
2011年2月25日
研究记录更新
最后更新发布 (估计)
2011年2月25日
上次提交的符合 QC 标准的更新
2011年2月23日
最后验证
2011年2月1日
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.