A Study of a Live Intranasal Influenza Vaccine in Children With Cancer (FMRESP)
October 12, 2011 updated by: St. Jude Children's Research Hospital
A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
FluMist is a live attenuated intranasal influenza vaccine
|
|
Active Comparator: 2
|
Inactivated influenza vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immunization response
Time Frame: 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).
|
10/31/2010
|
|
Flumist safety
Time Frame: 2 years
|
Describe the safety of FluMist and inactivated influenza vaccine.
|
2 years
|
|
Viral Replication
Time Frame: 1 year
|
Describe the incidence and duration of viral replication following immunization with FluMist.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Silvana Carr, MD, St. Jude Children's Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
May 19, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Estimate)
October 13, 2011
Last Update Submitted That Met QC Criteria
October 12, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMRESP
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