Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 3:11 AM
Study NCT ID:
NCT00906750
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2009-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMRESP
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: