Back to resultsInfluenza Vaccination in Bone Marrow Transplantation
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
inactivated split-virus influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Peripheral blood stem cell transplantation, Non-myeloabalative, Influenza vaccination, Humoral immune response, Immunogenicity
Eligibility Criteria
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.
Sites / Locations
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00419224
Brief Title
Influenza Vaccination in Bone Marrow Transplantation
Official Title
Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Cleveland Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Peripheral blood stem cell transplantation, Non-myeloabalative, Influenza vaccination, Humoral immune response, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
inactivated split-virus influenza vaccine
Primary Outcome Measure Information:
Title
Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif B Mossad, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Influenza Vaccination in Bone Marrow Transplantation
We'll reach out to this number within 24 hrs