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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Natasha Halasa, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01216332
First received: October 5, 2010
Last updated: October 31, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Natasha Halasa, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01216332     History of Changes
Other Study ID Numbers: VICC PED 1067
Study First Received: October 5, 2010
Last Updated: October 31, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014