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Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

2016年4月12日 更新者:Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

173

阶段

  • 第四阶段

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

    • Utah
      • Layton、Utah、美国、84041
      • Pleasant Grove、Utah、美国、84062
      • Provo、Utah、美国、84604
      • Salt Lake City、Utah、美国、84107
      • South Jordan、Utah、美国、84095

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

11个月 至 1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 :

  • Previously enrolled in study GRC28 and received 2 vaccinations of the assigned lot.
  • Considered to be in good health on the basis of reported medical history and history-directed physical evaluation.
  • Available for the duration of the study.
  • Parent/legal representative willing and able to provide informed consent.
  • Parent/legal representative able to attend all scheduled visits and comply with all trial procedures.
  • Parent/legal representative willing to permit venipuncture for purposes of collecting a blood sample.

Exclusion Criteria :

  • Receipt of any vaccine within the past 7 days (subjects may be deferred until after the seven days has passed.)
  • Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
  • Ever received any influenza vaccine, other than at Visits 1 and 2 of study GRC28, or known to have ever been diagnosed with laboratory-confirmed influenza.
  • An acute illness with fever (rectal temperature ≥ 100.4°F [38.0°C]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other interventional clinical trial within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in the study.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital, or developmental disorder that, in the opinion of the investigator, could interfere with trial conduct or completion.
  • Known Human Immunodeficiency Virus (HIV)-positive mother or Hepatitis B surface antigen (HBsAg)-positive mother.
  • Known HIV, Hepatitis B, or Hepatitis C infection.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Prior personal history of Guillain-Barré syndrome.
  • Any condition that, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the 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:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Fluzone®-Primed Group
Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
0.25 mL, Intramuscular
其他名称:
  • Fluzone®
实验性的:Fluzone®-Naive Group
Participants had never received Influenza vaccine and had received two doses of placebo in the fall of 2005 (Study GRC28, NCT00242424), will receive 2 doses of Fluzone® Pediatric 2006-2007 formulation.
0.25 mL, Intramuscular
其他名称:
  • Fluzone®

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 Seroprotected Participants Post-vaccination With Fluzone®
大体时间:Day 28 Post-vaccination
Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.
Day 28 Post-vaccination

次要结果测量

结果测量
措施说明
大体时间
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®
大体时间:Day 28 Post-vaccination
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Day 28 Post-vaccination

其他结果措施

结果测量
措施说明
大体时间
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone®
大体时间:Days 0-7 Post-vaccination
Solicited injection site: tenderness, erythema, and swelling; Solicited systemic reactions: fever, vomiting, abnormal crying, drowsiness, appetite loss, and irritability, after each vaccination
Days 0-7 Post-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。

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

2006年10月1日

初级完成 (实际的)

2007年6月1日

研究完成 (实际的)

2008年9月1日

研究注册日期

首次提交

2006年10月20日

首先提交符合 QC 标准的

2006年10月20日

首次发布 (估计)

2006年10月23日

研究记录更新

最后更新发布 (估计)

2016年4月14日

上次提交的符合 QC 标准的更新

2016年4月12日

最后验证

2016年4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.

Influenza Virus Vaccine, Fluzone®的临床试验

3
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