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

Vanderbilt University

Status and phase: Completed; Phase 1

Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia

Treatments: Drug: High-dose trivalent inactivated influenza vaccine; Drug: Standard dose trivalent inactivated influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01216332

VICC PED 1067

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

High-Dose trivalent inactivated influenza vaccine

Experimental group

Description:

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.

Treatment:

Drug: High-dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine

Active Comparator group

Description:

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

Treatment:

Drug: Standard dose trivalent inactivated influenza vaccine