Status:
COMPLETED
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Cancer
Eligibility:
All Genders
2-21 years
Phase:
PHASE1
Brief Summary
Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requi...
Detailed Description
The secondary objectives of this study are to: 1. Describe the safety of FluMist and inactivated influenza vaccine. 2. Describe the incidence and duration of viral replication following immunization ...
Eligibility Criteria
Inclusion
- Age 2 through 21 (not yet reached their 22nd birthday) at the time of entry into the study
- 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
- History of hypersensitivity to any component of FluMist or TIV, including egg or egg products, gelatin, or monosodium glutamate;
- 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;
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00906750
Start Date
October 1 2008
End Date
July 1 2011
Last Update
October 13 2011
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105