Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

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 Leukemia.

Detailed description:

Arms:
arm 1: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. arm 2: 0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine

Interventions: intervention 1: High-dose trivalent inactivated influenza vaccine intervention 2: Standard dose trivalent inactivated influenza vaccine
Intervention descriptions: intervention 1: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine. intervention 2: 0.5 mL standard dose trivalent inactivated influenza vaccine

Protocol document: