Trials / Completed
CompletedNCT00022035
Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia
Influenza Vaccine Immunogenicity in Children During and After Therapy for Acute Lymphoblastic Leukemia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 1 Year – 20 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OBJECTIVES: * Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine. * Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination. OUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months). Patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses. Patients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9. PROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | trivalent influenza vaccine |
Timeline
- Start date
- 2000-08-01
- Primary completion
- 2002-11-01
- First posted
- 2003-01-27
- Last updated
- 2013-01-31
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00022035. Inclusion in this directory is not an endorsement.