H1N1 Pandemic Flu的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

完全的

条件

H1N1 Pandemic Flu

详细说明

This is a prospective observational study. This study will not dictate vaccine administration, nor the vaccine product to be used. It will collect data in St Jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. Research participants will receive two doses of inactivated H1N1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15 mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose is counted as day 0. At each of these visits, blood will be collected to assess for immunogenicity. Research participants will be given a diary card to record symptoms for 28 days . They will be asked to bring this diary back at the next visit. Other vaccine-related adverse events will also be collected by retrospective chart review.

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.

研究类型

观察性的

注册 (实际的)

104

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

美国
- Tennessee
  - Memphis、Tennessee、美国、38105
    - St.Jude Children's Research Hospital

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 21年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care. Stem cell transplant recipients in the first year following their transplant are excluded.

描述

Inclusion Criteria:

Age 6 months through 21 years of age at the time of entry into the study;
Body weight of 13 kg or greater at the time of entry into the study;
Participant is immunocompromised due to cancer, HIV, or sickle cell disease or receipt of a stem cell transplant;
Participant or participant's parent/legal guardian available by telephone during the course of the study;
Written informed consent (and assent, if applicable) obtained;
Potential research participant received or will receive H1N1 swine-origin monovalent influenza vaccine within 24 hours of study entry.

Exclusion Criteria:

Proven history, by RT-PCR, of H1N1 swine-origin influenza infection prior to study entry;
Receipt of a stem cell transplant within one year prior to study entry;
Participation in P1088 study.

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

观测模型：仅案例
时间观点：预期

团体/队列数

1

队列和干预

团体/队列
H1N1 pandemic influenza vaccine recipient Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.

团体/队列

H1N1 pandemic influenza vaccine recipient

Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight with underlying conditions of cancer, HIV, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.Target total accrual of up to 400 children and young adults stratified based on their underlying diagnosis as follows: 150 children or young adults with cancer, 100 with human immunodeficiency virus (HIV), 100 with sickle cell disease, and 50 with receipt of a stem cell transplant more than a year prior to study entry.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
This study will document Seroprotection (a post-vaccine antibody response ≥ an HI titer of 1:40). 大体时间：1.5 years	1.5 years

次要结果测量

结果测量	大体时间
This study will document seroconversion rates (a 4-fold or greater rise in HI titer comparing pre- and post-vaccine sera). 大体时间：1.5 years	1.5 years

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

St. Jude Children's Research Hospital

调查人员

首席研究员：Hana Hakim, MD、St. Jude Children's Research Hospital

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。

有用的网址

St. Jude Children's Research Hospital

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10月1日

初级完成 (实际的)

2011年6月1日

研究完成 (实际的)

2011年6月1日

研究注册日期

首次提交

2009年10月19日

首先提交符合 QC 标准的

2009年10月22日

首次发布 (估计)

2009年10月23日

研究记录更新

最后更新发布 (估计)

2011年10月7日

上次提交的符合 QC 标准的更新

2011年10月5日

最后验证

2011年10月1日

Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults