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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Natasha Halasa, Vanderbilt University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01216332
First Posted: October 7, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Natasha Halasa, Vanderbilt University
  Purpose
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.

Condition Intervention Phase
Pediatric Patients With Acute Lymphoblastic Leukemia Drug: High-dose trivalent inactivated influenza vaccine Drug: Standard dose trivalent inactivated influenza vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Natasha Halasa, Vanderbilt University:

Primary Outcome Measures:
  • To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in pediatric Acute Lymphoblastic Leukemia subjects [ Time Frame: About 6 months after last dose of vaccine ]

Secondary Outcome Measures:
  • Compare humoral immune responses of pediatric Acute Lymphoblastic Leukemia patients to influenza virus antigens included in trivalent inactivated influenza vaccine after high and standard doses of trivalent inactivated influenza vaccine. [ Time Frame: About 6 months after last dose of vaccine. ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216332


Locations
United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Natasha Halasa, M.D. Vanderbilt Universtiy Medical Center
  More Information

Responsible Party: Natasha Halasa, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01216332     History of Changes
Other Study ID Numbers: VICC PED 1067
First Submitted: October 5, 2010
First Posted: October 7, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2011

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs