NCT00626808

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

A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 321,697 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 of age with a claim associated with a diagnosis of asthma * Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing * Children 24-59 months of age with immunosuppression * To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist * To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations

Conditions

• Asthma
• Wheezing
• Immunosuppression

Interventions

Type	Name	Description
DRUG	No Intervention	There were no interventions. No subjects were enrolled in this retrospective database study.

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-02-29
• Last updated: 2014-08-12
• Results posted: 2014-08-12

Locations

1 site across 1 country: United States