Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
2015年9月16日 更新者：Novartis
A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US.
The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
研究概览
研究类型
介入性
注册 (实际的)
1893
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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Buenos Aires、阿根廷
- Site 2: C1425AWK
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Cordoba、阿根廷
- Site 1: X5000BJH
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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
3年 至 64年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy subjects 3 to 64 years of age
Exclusion Criteria:
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
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 |
|---|---|
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实验性的：Influenza virus vaccine
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Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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有源比较器：Comparator influenza vaccine
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Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
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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 |
|---|---|---|
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Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
大体时间：21 days after vaccination
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To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age.
The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
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21 days after vaccination
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Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
大体时间：21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase).
According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
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21 days after vaccination
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
大体时间：7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
大体时间：21 days after vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
大体时间：21 days after vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
大体时间：21 days after vaccination
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To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
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21 days after vaccination
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Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
大体时间：7 days after vaccination
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Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
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7 days after vaccination
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Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
大体时间：50 days after last vaccination
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To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
大体时间：50 days after last vaccination
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Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
大体时间：50 days after last vaccination
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To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
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50 days after last vaccination
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Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
大体时间：7 days after each vaccination
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Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
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7 days after each vaccination
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Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
大体时间：21 days after vaccination
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Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
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21 days after 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。
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。
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
2007年4月1日
初级完成 (实际的)
2007年7月1日
研究完成 (实际的)
2007年12月1日
研究注册日期
首次提交
2007年4月23日
首先提交符合 QC 标准的
2007年4月23日
首次发布 (估计)
2007年4月24日
研究记录更新
最后更新发布 (估计)
2015年10月1日
上次提交的符合 QC 标准的更新
2015年9月16日
最后验证
2015年9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.