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Influenza Vaccination in Bone Marrow Transplantation

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00419224
First received: January 5, 2007
Last updated: January 9, 2007
Last verified: January 2007
History of Changes

January 5, 2007
January 9, 2007
October 2002
Not Provided
Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
Same as current
Complete list of historical versions of study NCT00419224 on ClinicalTrials.gov Archive Site
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Influenza Vaccination in Bone Marrow Transplantation
Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls

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

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: inactivated split-virus influenza vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2003
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Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00419224
4675, RPC 6817
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The Cleveland Clinic
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Principal Investigator: Sherif B Mossad, MD The Cleveland Clinic
The Cleveland Clinic
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP