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

MedImmune

Status: Completed

Conditions: Wheezing; Asthma; Immunosuppression

Treatments: Drug: No Intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00626808

MI-MA175

Details and patient eligibility

About

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

Full 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

Enrollment: 321,697 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

321,697 participants in 4 patient groups

1

Description:

Children less than 24 months of age

Treatment:

Drug: No Intervention

2

Description:

Children 24 to 59 months of age with a claim associated with a diagnosis of asthma

Treatment:

Drug: No Intervention

3

Description:

Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing

Treatment:

Drug: No Intervention

4

Description:

Children 24-59 months of age with immunosuppression

Treatment:

Drug: No Intervention