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

Primary Purpose

Pediatric Patients With Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-dose trivalent inactivated influenza vaccine
Standard dose trivalent inactivated influenza vaccine
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Patients With Acute Lymphoblastic Leukemia

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-Dose trivalent inactivated influenza vaccine

Standard dose trivalent inactivated influenza vaccine

Arm 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.

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

Outcomes

Primary Outcome Measures

Local Reactions After Each Vaccination
Number of participants with local reactions after each vaccination
Systemic Reaction
Number of participants with systemic reactions after each vaccination

Secondary Outcome Measures

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)
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)
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)
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)
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)

Full Information

First Posted
October 5, 2010
Last Updated
April 29, 2019
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01216332
Brief Title
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Patients With Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Dose trivalent inactivated influenza vaccine
Arm Type
Experimental
Arm 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.
Arm Title
Standard dose trivalent inactivated influenza vaccine
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
High-dose trivalent inactivated influenza vaccine
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Standard dose trivalent inactivated influenza vaccine
Intervention Description
0.5 mL standard dose trivalent inactivated influenza vaccine
Primary Outcome Measure Information:
Title
Local Reactions After Each Vaccination
Description
Number of participants with local reactions after each vaccination
Time Frame
From baseline to 7 days after each vaccination
Title
Systemic Reaction
Description
Number of participants with systemic reactions after each vaccination
Time Frame
From baseline to 7 days after each vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise
Description
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.
Title
Immunogenicity:Number of Participants With a Pre-titer ≥1:40
Description
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.
Title
Immunogenicity: Number of Participants With a Post-titer ≥1:40
Description
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.
Title
Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants
Description
Geometric mean titers pre-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
Time Frame
baseline
Title
Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants
Description
Geometric mean titers post-vaccine (A/California/7/09/H1N1, A/Perth/16/2009/ H3N2, B/Brisbane/60/2008)
Time Frame
About 6 months after last dose of vaccine.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Halasa, M.D.
Organizational Affiliation
Vanderbilt Universtiy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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