A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA
2017年10月18日 更新者：Seqirus
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults
研究概览
研究类型
介入性
注册 (实际的)
1313
阶段
- 阶段2
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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Alabama
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Huntsville、Alabama、美国、35802
- Study Site
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California
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San Diego、California、美国、92108
- Study Site
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Florida
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Melbourne、Florida、美国、32935
- Study Site
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Illinois
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Peoria、Illinois、美国、61602
- Study Site
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Indiana
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South Bend、Indiana、美国、46601
- Study Site
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Louisiana
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Metairie、Louisiana、美国、70006
- Study Site
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Maryland
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Baltimore、Maryland、美国、21205
- Study Site
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Rockville、Maryland、美国、20850
- Study Site
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Texas
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Austin、Texas、美国、78705
- Study Site
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Fort Worth、Texas、美国、76135
- Study Site
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Utah
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Salt Lake City、Utah、美国、84124
- Study 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 or female aged 18 and older, inclusive, at the time of providing informed consent.
- Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.
Exclusion Criteria:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：CSL425（30 微克）
每剂量 30 mcg 血凝素抗原。
第 0 天和第 21 天手臂三角肌区域肌肉注射 0.5 mL
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CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
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实验性的：CSL425 (7.5 mcg)
7.5 mcg of hemagglutinin antigen per dose.
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
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CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
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实验性的：CSL425 (15 mcg)
15 mcg of hemagglutinin antigen per dose.
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
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CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
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安慰剂比较：Placebo
Vaccine diluent.
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
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Vaccine diluent, thimerosal 0.01% (weight/volume).
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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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Seroconversion Rate 21 Days After the First Vaccination
大体时间：21 days after the first vaccination
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Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer.
Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
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21 days after the first vaccination
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Seroconversion Rate 21 Days After the Second Vaccination
大体时间：21 days after the second vaccination
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Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer.
Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
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21 days after the second vaccination
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Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
大体时间：21 days after the first vaccination
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21 days after the first vaccination
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Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
大体时间：21 days after the second vaccination
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21 days after the second 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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Frequency and Intensity of Solicited Adverse Events After the First Vaccination
大体时间：During the 7 days after the first vaccination
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Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
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During the 7 days after the first vaccination
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Duration of Solicited Local Adverse Events After the First Vaccination
大体时间：During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
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During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
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Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
大体时间：Up to 180 days after the last vaccination
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A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
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Up to 180 days after the last vaccination
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Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
大体时间：Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
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Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities. |
Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI
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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
调查人员
- 研究主任：Director, Vaccines Clinical Development、Seqirus
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
2009年8月1日
初级完成 (实际的)
2009年11月1日
研究完成 (实际的)
2010年4月1日
研究注册日期
首次提交
2009年8月12日
首先提交符合 QC 标准的
2009年8月12日
首次发布 (估计)
2009年8月13日
研究记录更新
最后更新发布 (实际的)
2017年11月21日
上次提交的符合 QC 标准的更新
2017年10月18日
最后验证
2017年10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.