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

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

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 Overview

• Status: Completed
• Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: High-dose trivalent inactivated influenza vaccine; Drug: Standard dose trivalent inactivated influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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	Drug: Standard dose trivalent inactivated influenza vaccine; 0.5 mL standard dose trivalent inactivated influenza vaccine

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Natasha Halasa, M.D., Vanderbilt Universtiy Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VICC PED 1067