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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pediatric Patients With Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: High-dose trivalent inactivated influenza vaccine
* Drug: Standard dose trivalent inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Dose trivalent inactivated influenza vaccine<br>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: High-dose trivalent inactivated influenza vaccine<br>* 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.<br>|
| Active Comparator: Standard dose trivalent inactivated influenza vaccine<br>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 | Drug: Standard dose trivalent inactivated influenza vaccine<br>* 0.5 mL standard dose trivalent inactivated influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Reactions After Each Vaccination | Number of participants with local reactions after each vaccination | From baseline to 7 days after each vaccination | 
| Systemic Reaction | Number of participants with systemic reactions after each vaccination | From baseline to 7 days after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | About 6 months after last dose of vaccine. |