Spots Global Cancer Trial Database for A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
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Trial Identification
Brief Title: A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
Official Title: A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer
Study ID: NCT00906750
Conditions
Study Description
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 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.
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 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).
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Contact Details
Name: Silvana Carr, MD
Affiliation: St. Jude Children's Research Hospital
Role: PRINCIPAL_INVESTIGATOR
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