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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Treatments: Vaccines

Criteria

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.