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

Vanderbilt University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pediatric Patients With Acute Lymphoblastic Leukemia

Interventions

High-dose trivalent inactivated influenza vaccineDRUG

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.

Standard dose trivalent inactivated influenza vaccineDRUG

0.5 mL standard dose trivalent inactivated influenza vaccine

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Local Reactions After Each Vaccination

Number of participants with local reactions after each vaccination

Time frame: From baseline to 7 days after each vaccination

Systemic Reaction

Number of participants with systemic reactions after each vaccination

Time frame: From baseline to 7 days after each vaccination

Secondary Outcomes

Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise

Greater than or equal to a Fourfold titer rise three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame: About 6 months after last dose of vaccine.

Immunogenicity:Number of Participants With a Pre-titer ≥1:40

Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame: About 6 months after last dose of vaccine.

Immunogenicity: Number of Participants With a Post-titer ≥1:40

Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame: About 6 months after last dose of vaccine.

Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants

Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Time frame: baseline

Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants

Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)

Data from ClinicalTrials.gov

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