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

Completed · Phase 1

Conditions studied: Pediatric Patients With Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT01216332

Run by

Vanderbilt University

People needed

50

Starts

2010-10-01

Expected to finish

2013-05-01

Last updated by the study team

2019-05-03

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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