Status:
COMPLETED
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
RTI International
Conditions:
Asthma
Wheezing
Eligibility:
All Genders
Brief Summary
This is a retrospective cohort study of children included in a large medical insurance claims database.
Detailed Description
* To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations: * Children younger than 24 months of age * Children 24-59 months o...
Eligibility Criteria
Inclusion
- Children less than 24 months of age during August through January/February.
- Children \<24 to 59 months of age during August through January/February, with:
- two outpatient claims for asthma, or
- one inpatient/emergency room claim for asthma, or
- one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
- Children \<24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
- Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
321697 Patients enrolled
Trial Details
Trial ID
NCT00626808
Start Date
October 1 2007
End Date
March 1 2010
Last Update
August 12 2014
Active Locations (1)
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1
Research Site
Research Triangle Park, North Carolina, United States