Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
2009年12月29日 更新者:Centers for Disease Control and Prevention, China
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
研究概览
地位
未知
条件
研究类型
介入性
注册 (预期的)
900
阶段
- 第三阶段
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
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Guangxi
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Guilin、Guangxi、中国、541000
- 招聘中
- Lingchuan County CDC
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接触:
- Yanping Li, Doctor
- 电话号码:0773 6812175
- 邮箱:lyp898@163.com
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Hunan
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Xiangxi Prefecture、Hunan、中国、416100
- 招聘中
- Luxi County CDC
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接触:
- Fangjun Li, Doctor
- 电话号码:0743 4265397
- 邮箱:fangjunliself678@sina.com
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Jiangsu
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Yancheng、Jiangsu、中国、224001
- 招聘中
- Yandu District CDC
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接触:
- Yuemei Hu, Doctor
- 电话号码:0515 8324084
- 邮箱:993832717@qq.com
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-
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
6个月 至 2年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
- Family members of the employees or the Investigator
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- Confirmed infection with the novel influenza A/H1N1 strain
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
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:预防
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:7.5ug H1N1 vaccine
360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.
|
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
实验性的:15ug H1N1 vaccine
360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.
|
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
安慰剂比较:seasonal influenza vaccine
180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.
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0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
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
2009年12月1日
初级完成 (预期的)
2010年2月1日
研究完成 (预期的)
2010年6月1日
研究注册日期
首次提交
2009年12月24日
首先提交符合 QC 标准的
2009年12月24日
首次发布 (估计)
2009年12月25日
研究记录更新
最后更新发布 (估计)
2009年12月30日
上次提交的符合 QC 标准的更新
2009年12月29日
最后验证
2009年12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.