A Study of a Live Intranasal Influenza Vaccine in Children With Cancer

Study Overview
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Brief Summary
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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
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The secondary objectives of this study are to: Describe the safety of FluMist and inactivated influenza vaccine. Describe the incidence and duration of viral replication following immunization with FluMist. 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).

Official Title
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A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

Conditions
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Cancer

Intervention / Treatment
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* Biological: FluMist
* Biological: Inactivated influenza vaccine


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: FluMist<br>* FluMist is a live attenuated intranasal influenza vaccine<br>|
| Active Comparator: 2<br> | Biological: Inactivated influenza vaccine<br>* Inactivated influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 10/31/2010 | 
| Flumist safety | Describe the safety of FluMist and inactivated influenza vaccine. | 2 years | 
| Viral Replication | Describe the incidence and duration of viral replication following immunization with FluMist. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FLuMIST, Inactivated influenza vaccine, Study of FluMist versus inactivated influenza vaccine in children with cancer