Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
3 Years
17 Years
Both
Pediatric Patients With Acute Lymphoblastic Leukemia
Trial Information
Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
Inclusion Criteria:
- Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
- Must be in 1st complete remission.
- Must be 4 weeks into maintenance therapy.
- 17 years of age, inclusive.
- Available for duration of study.
Exclusion Criteria:
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to
eggs/egg protein.
- History of Guillain-Barre syndrome.
- Evidence of relapsed disease.
- 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.
- History of receiving 2010 - 2011 influenza vaccine.
- Pregnant female.
- History of proven influenza disease after September 1, 2010.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric Acute Lymphoblastic Leukemia subjects
Outcome Time Frame:
About 6 months after last dose of vaccine
Safety Issue:
Yes
Principal Investigator
Natasha Halasa, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt Universtiy Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
VICC PED 1067
NCT ID:
NCT01216332
Start Date:
October 2010
Completion Date:
April 2012
Related Keywords:
- Pediatric Patients With Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Name | Location |
|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville, Tennessee 37232 |
