Cancer
Conditions
Keywords
FLuMIST, Inactivated influenza vaccine, Study of FluMist versus inactivated influenza vaccine in children with cancer
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).
Interventions
BIOLOGICALFluMist
FluMist is a live attenuated intranasal influenza vaccine
BIOLOGICALInactivated influenza vaccine
Inactivated influenza vaccine
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flumist safety | 2 years | Describe the safety of FluMist and inactivated influenza vaccine. |
| Viral Replication | 1 year | Describe the incidence and duration of viral replication following immunization with FluMist. |
| Immunization response | 10/31/2010 | 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). |
Countries
United States
Outcome results
None listed