NCT01216332

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Patients With Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	High-dose trivalent inactivated influenza vaccine	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.
DRUG	Standard dose trivalent inactivated influenza vaccine	0.5 mL standard dose trivalent inactivated influenza vaccine

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-10-07
• Last updated: 2019-05-03
• Results posted: 2019-05-03

Locations

1 site across 1 country: United States