Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions
2016年11月3日 更新者：Seqirus
Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.
Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.
研究概览
研究类型
介入性
注册 (实际的)
540
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、10117
- 001, Novartis Investigational Site
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Dresden、德国、01307
- 003, Novartis Investigational Site
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Hamburg、德国、20359
- 005, Novartis Investigational Site
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Magdeburg、德国、39120
- 006, Novartis Investigational Site
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Rostock、德国、18055
- 004, Novartis Investigational Site
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Wuerzburg、德国、97070
- 002, Novartis 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
18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:
- - Male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry;
- Individuals who are able to comply with all study procedures and requirements;
- Healthy volunteers and volunteers specifically with underlying COPD, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible;
- Please contact the site for additional eligibility criteria.
Exclusion Criteria:
- Individuals who are not able to follow all the required study procedures for the whole period of the study;
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study;
- Please contact the site for additional eligibility criteria.
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：第 1 组：aH5N1 成人
aH5N1 健康和不健康的成人
|
2 剂 0.5 毫升，间隔 3 周
|
|
实验性的：第 2 组：aH5N1 老人
aH5N1 健康和不健康的老年人
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2 剂 0.5 毫升，间隔 3 周
|
|
有源比较器：第 3 组：aTIV 成人
aTIV 健康和不健康的成年人
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2 剂 0.5 毫升，间隔 3 周
|
|
有源比较器：第 4 组：aTIV 老年人
aTIV 健康和不健康的老年人
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2 剂 0.5 毫升，间隔 3 周
|
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 |
|---|---|---|
|
Percentage of subjects achieving seroconversion
大体时间：day 43
|
Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10])
|
day 43
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|
通过 HI 测定确定的几何平均比 (GMR)
大体时间：第43天
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第43天
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HI 滴度≥1:40 的受试者百分比
大体时间：第43天
|
第43天
|
|
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请求和未经请求的不良事件
大体时间：第202天
|
在合并的年龄组中，18 岁及以上健康或有基础疾病且已接种 aTIV 或 aH5N1 疫苗的受试者。
|
第202天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Geometric mean titers (GMTs) as determined by HI
大体时间：day 1
|
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
|
day 1
|
|
Geometric mean ratios (GMRs) as determined by SRH
大体时间：day 22
|
day 22
|
|
|
Percentage of subjects with an HI titer ≥1:40
大体时间：day 22
|
day 22
|
|
|
Percentage of subjects achieving seroconversion
大体时间：day 22
|
Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2])
|
day 22
|
|
Percentage of subjects with geometric mean area ≥25 mm2
大体时间：day 43
|
day 43
|
|
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Percentage of subjects achieving seroconversion
大体时间：day 22
|
Seroconversion is defined as HI ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10])
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day 22
|
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GMTs as determined by SRH
大体时间：day 43 (3 weeks after the second vaccination)
|
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
|
day 43 (3 weeks after the second vaccination)
|
|
GMRs as determined by HI
大体时间：day 22
|
day 22
|
|
|
Geometric mean titers (GMTs) as determined by HI
大体时间：day 43 (3 weeks after the second vaccination)
|
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
|
day 43 (3 weeks after the second vaccination)
|
|
Geometric mean titers (GMTs) as determined by HI
大体时间：day 22 (3 weeks after the first vaccination)
|
HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
|
day 22 (3 weeks after the first vaccination)
|
|
GMRs as determined by SRH
大体时间：day 43
|
day 43
|
|
|
Percentage of subjects with an HI titer ≥1:40
大体时间：day 1
|
day 1
|
|
|
Percentage of subjects with geometric mean area ≥25 mm2
大体时间：day 1
|
day 1
|
|
|
Percentage of subjects with geometric mean area ≥25 mm2
大体时间：day 22
|
day 22
|
|
|
Percentage of subjects achieving seroconversion
大体时间：day 43
|
Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2])
|
day 43
|
|
GMTs as determined by SRH
大体时间：day 1
|
Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition
|
day 1
|
|
Geometric mean ratios (GMRs) as determined by SRH
大体时间：day 43 (3 weeks after the second vaccination)
|
day 43 (3 weeks after the second vaccination)
|
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。
赞助
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。
一般刊物
- Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 25.
- Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. Erratum In: PLoS ONE. 2009;4(3). doi: 10.1371/annotation/5f2ae0fb-53f1-48c2-aa19-9114765ba029. Capecchi, Pamela [corrected to Capecchi, Pier Leopoldo].
- Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80. doi: 10.1016/s0264-410x(00)00499-0.
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
2014年4月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2014年3月7日
首先提交符合 QC 标准的
2014年3月17日
首次发布 (估计)
2014年3月19日
研究记录更新
最后更新发布 (估计)
2016年11月4日
上次提交的符合 QC 标准的更新
2016年11月3日
最后验证
2016年11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.