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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00419224 |
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Date of registration:
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05/01/2007 |
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Primary sponsor: |
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Public title:
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Influenza Vaccination in Bone Marrow Transplantation
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Scientific title:
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Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls |
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Date of first enrolment:
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October 2002 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00419224 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Sherif B Mossad, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Biological: inactivated split-virus influenza vaccine
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Primary Outcome(s)
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Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response?
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Secondary ID(s)
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4675
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RPC 6817
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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