Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients
18 Years
N/A
Both
Adult Stem Cell Hematopoetic Transplant
Trial Information
Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients
Inclusion Criteria:
- Allogeneic hematopoietic stem cell transplant recipients who are >6 post-transplant
- greater than or equal to 18 years of age
- Available for duration of study
- If patients are on immunosuppressive therapy for treatment of graft versus host
disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses
will be eligible.
Exclusion Criteria:
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to
eggs/egg protein
- History of Guillain-Barre syndrome
- Evidence of hematologic malignancy or disease relapse post-transplant (mixed
chimerisms and molecular evidence of disease is permitted)
- Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
- History of receiving 2011 - 2012 influenza vaccine
- History of proven influenza disease after September 1, 2011.
- Pregnant females
- Have any condition that would, in the opinion of the site investigator, place them at
an unacceptable risk of injury or render them unable to meet the requirements of the
protocol
- Have any condition that the investigator believes may interfere with successful
completion of the study
- Platelet count less than 50,000 cells/μL
- History of known infection with HIV, Hepatitis B or Hepatitis C
- History of known latex hypersensitivity
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Outcome Description:
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.
Outcome Time Frame:
Day of TIV to 7 days after TIV
Safety Issue:
Yes
Principal Investigator
Natasha Halasa, M.D., M.P.H.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt University
Authority:
United States: Food and Drug Administration
Study ID:
VICC BMT 1057
NCT ID:
NCT01215734
Start Date:
October 2010
Completion Date:
September 2012
Related Keywords:
- Adult Stem Cell Hematopoetic Transplant
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program | Nashville, Tennessee 37232 |
