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
  Purpose

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


Condition Intervention Phase
Influenza
Biological: inactivated split-virus influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

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?

Estimated Enrollment: 36
Study Start Date: October 2002
Estimated Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419224

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Sherif B Mossad, MD The Cleveland Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00419224     History of Changes
Other Study ID Numbers: 4675, RPC 6817
Study First Received: January 5, 2007
Last Updated: January 9, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Peripheral blood stem cell transplantation
Non-myeloabalative
Influenza vaccination
Humoral immune response
Immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014