Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
2016年9月14日 更新者:GlaxoSmithKline
To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years
The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine.
For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
157
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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Berlin、德国、10315
- GSK Investigational Site
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Berlin、德国、12627
- GSK Investigational Site
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Berlin、德国、13355
- GSK Investigational Site
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Mecklenburg-Vorpommern
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Buetzow、Mecklenburg-Vorpommern、德国、18246
- GSK Investigational Site
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Rostock、Mecklenburg-Vorpommern、德国、18106
- GSK Investigational Site
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Sachsen
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Bischofswerda、Sachsen、德国、01877
- GSK Investigational Site
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Coswig、Sachsen、德国、01640
- GSK Investigational Site
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Dresden、Sachsen、德国、01307
- GSK Investigational Site
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Dresden、Sachsen、德国、01169
- GSK Investigational Site
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Leipzig、Sachsen、德国、04209
- GSK Investigational Site
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Schleswig-Holstein
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Bad Segeberg、Schleswig-Holstein、德国、23795
- GSK Investigational Site
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Flensburg、Schleswig-Holstein、德国、24937
- GSK Investigational Site
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Husum、Schleswig-Holstein、德国、25813
- GSK Investigational Site
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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 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
- All children included in the study must never have been given a prophylactic influenza inoculation.
- Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.
Exclusion Criteria:
- Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
- Acute disease at the beginning of the study
- Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.
- Known allergic reactions that might have been caused by one or more components of the vaccine.
- Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.
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: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:Group A
Subjects aged between 6 months and 3 years.
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2 doses, intramuscular injection
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实验性的:Group B
Subjects aged 3 to 6 years.
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2 doses, intramuscular injection
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有源比较器:Group C
Subjects aged between 6 months and 3 years.
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2 doses, intramuscular injection
其他名称:
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有源比较器:Group D
Subjects aged 3 to 6 years.
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2 doses, intramuscular injection
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
大体时间:On Day 21 (+- 2) after the second vaccination
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On Day 21 (+- 2) after the second vaccination
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次要结果测量
结果测量 |
大体时间 |
---|---|
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
大体时间:Within 4 days after each vaccination
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Within 4 days after each vaccination
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Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
大体时间:Within 30 days after each vaccination
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Within 30 days after each vaccination
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Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
大体时间:Throughout the study
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Throughout the study
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GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
大体时间:On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
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On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2003年10月1日
初级完成 (实际的)
2004年8月1日
研究完成 (实际的)
2004年8月1日
研究注册日期
首次提交
2008年8月7日
首先提交符合 QC 标准的
2008年8月7日
首次发布 (估计)
2008年8月11日
研究记录更新
最后更新发布 (估计)
2016年9月15日
上次提交的符合 QC 标准的更新
2016年9月14日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 100351
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
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研究协议
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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临床研究报告
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
个人参与者数据集
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
带注释的病例报告表
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符:100351信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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.