NCT00022035

Brief Summary

RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia. PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

August 10, 2001

Last Update Submit

January 30, 2013

Conditions

InfectionLeukemia

Keywords

childhood acute lymphoblastic leukemia in remissioninfection

Interventions

trivalent influenza vaccineBIOLOGICAL

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia * In first remission after completion of induction chemotherapy * Currently on active treatment OR * Completed treatment within the past 6 months PATIENT CHARACTERISTICS: Age: * 1 to 20 at time of diagnosis Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Pulmonary: * No acute respiratory distress Other: * No history of Guillain-Barre syndrome * No history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal * No febrile illness with fever over 100.4 degrees F * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

InfectionsLeukemia

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Martin L. Brecher, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

November 1, 2002

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(2)