Status:
COMPLETED
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Lead Sponsor:
Vanderbilt University
Conditions:
Pediatric Patients With Acute Lymphoblastic Leukemia
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
Brief Summary
This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01216332
Start Date
October 1 2010
End Date
May 1 2013
Last Update
May 3 2019
Active Locations (1)
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1
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232