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

Phase 1

Completed

Interventions: Drug: High-dose trivalent inactivated influenza vaccine
Drug: Standard dose trivalent inactivated influenza vaccine

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
High-Dose trivalent inactivated influenza vaccine	High-dose trivalent inactivated influenza vaccine	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 vaccine	Standard dose trivalent inactivated influenza vaccine	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

Primary Outcome Measures

Name	Time	Method
Systemic Reaction	From baseline to 7 days after each vaccination	Number of participants with systemic reactions after each vaccination
Local Reactions After Each Vaccination	From baseline to 7 days after each vaccination	Number of participants with local reactions after each vaccination

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants	About 6 months after last dose of vaccine.	Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise	About 6 months after last dose of vaccine.	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)
Immunogenicity:Number of Participants With a Pre-titer ≥1:40	About 6 months after last dose of vaccine.	Pre-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants	baseline	Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
Immunogenicity: Number of Participants With a Post-titer ≥1:40	About 6 months after last dose of vaccine.	Post-titer ≥1:40 for three strains (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)