A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a retrospective cohort study of children included in a large medical insurance claims database.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Collaborator: RTI International

Criteria

• 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.