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临床试验/NCT00419224
NCT00419224已完成4 期

Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2002年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
36
试验地点
2
主要终点
Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?

研究概览

简要总结

The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

详细描述

Patients who receive bone marrow transplantation are at high risk for complications from influenza infection. It is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called "nonmyeloablative", or "reduced intensity" bone marrow transplantation. This study compares the response to influenza vaccination in a group of these patients to that in healthy people.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years.
  • Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination.

排除标准

  • Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy.
  • Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

结局指标

主要结局

Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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