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 requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.
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 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
56
FluMist is a live attenuated intranasal influenza vaccine
Inactivated influenza vaccine
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
The primary objective of this study is to describe the immune response of FluMist compared with inactivated influenza vaccine in mild to moderately immunocompromised children with cancer
Time frame: 6 months
Immunization response
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).
Time frame: 10/31/2010
Flumist safety
Describe the safety of FluMist and inactivated influenza vaccine.
Time frame: 2 years
Viral Replication
Describe the incidence and duration of viral replication following immunization with FluMist.
Time frame: 1 year
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