A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
NCT ID: NCT00906750
Last Updated: 2011-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2008-10-31
2011-07-31
Brief Summary
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Detailed Description
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1. Describe the safety of FluMist and inactivated influenza vaccine.
2. Describe the incidence and duration of viral replication following immunization with FluMist.
3. To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
FluMist
FluMist is a live attenuated intranasal influenza vaccine
2
Inactivated influenza vaccine
Inactivated influenza vaccine
Interventions
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FluMist
FluMist is a live attenuated intranasal influenza vaccine
Inactivated influenza vaccine
Inactivated influenza vaccine
Eligibility Criteria
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Inclusion Criteria
* Participant or participants parent/legal guardian available by telephone during the course of the study;
* Written informed consent (and assent, if applicable) obtained
* Currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or have received chemotherapy in the past 12 weeks;
* If the participant's underlying cancer is a solid tumor, current status must be stable disease, partial response, or complete response to therapy; if the participant's underlying disease is a hematological malignancy, current status must be in remission, and if receiving chemotherapy, must be in the "continuation" or "maintenance" phase of therapy or equivalent;
* Estimated life expectancy of \> 1 year
Exclusion Criteria
* History of hypersensitivity to gentamicin;
* Close contact with a severely immunocompromised patient (e.g., a hematopoietic stem cell transplant patient, during those periods in which the immunocompromised patient requires care in a protective environment
* History of Guillain-Barre´ syndrome;
* History of asthma;
* Female who is breastfeeding or lactating;
2 Years
21 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Silvana Carr, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Carr S, Allison KJ, Van De Velde LA, Zhang K, English EY, Iverson A, Daw NC, Howard SC, Navid F, Rodriguez-Galindo C, Yang J, Adderson EE, McCullers JA, Flynn PM. Safety and immunogenicity of live attenuated and inactivated influenza vaccines in children with cancer. J Infect Dis. 2011 Nov 15;204(10):1475-82. doi: 10.1093/infdis/jir561. Epub 2011 Sep 23.
Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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FMRESP
Identifier Type: -
Identifier Source: org_study_id