Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients

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

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 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.