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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: |
NCT01215981 |
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Date of registration:
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05/10/2010 |
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Primary sponsor: |
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Public title:
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Influenza Vaccine Post Allogeneic Transplant
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Scientific title:
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MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed? |
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Date of first enrolment:
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September 2010 |
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Target sample size:
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73 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01215981 |
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Study type:
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Interventional |
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Study design:
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Allocation: 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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Michael Verneris, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Masonic Cancer Center, University of Minnesota |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient Population
- HSCT recipients who are greater than 60 days post transplant.
- Age 6 months and older who are greater than 60 days post post allogeneic
hematopoietic cell transplant
- Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no
known disease relapse
- No history of previous allergic reaction to influenza vaccine, known egg allergy
or Guillan-Barre Syndrome
- No flu vaccine in previous 4 months, no Campath in previous 6 months, no
intravenous immune globulin (IVIG) in previous 3 months
- Controls:
- Age 18 to 50 years
- No history of previous allergic reaction to influenza vaccine, known egg allergy
or Guillan-Barre Syndrome
- No flu vaccine in previous 4 months
Age minimum:
6 Months
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hematologic Malignancy
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Hematopoietic Stem Cell Transplant
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Intervention(s)
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Biological: Influenza vaccine
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Primary Outcome(s)
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Immune Response to Vaccine
[Time Frame: 8 Weeks After Vaccination]
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Secondary ID(s)
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1007M86296
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2010NTLS050
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MT2010-08R
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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