Influenza Vaccine Post Allogeneic Transplant
Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hematopoietic Stem Cell Transplant; Hematologic Malignancy
Intervention: Influenza vaccine (Biological); Influenza vaccine (Biological)
Phase: N/A
Status: Terminated
Sponsored by: Masonic Cancer Center, University of Minnesota Official(s) and/or principal investigator(s):
Michael Verneris, M.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota
Summary
Study Design:
This is a randomized, single center study to evaluate immune responses to the seasonal
influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who
receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy
adult volunteers will be recruited as controls to confirm immune response to a single
influenza vaccine.
Clinical Details
Official title: MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Immune Response to Vaccine
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota 55455, United States
Additional Information
Starting date: September 2010
Last updated: May 16, 2012
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