A Post Marketing Evaluation of the Effectiveness For Use of FluMist Among Children

• Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged less than 24 months. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged 24 to 59 months with a claims-based diagnosis of asthma. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged 24 to 59 months dispensed medication for wheezing. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• Evaluate the demographics and rate of vaccination with FluMist and other influenza vaccines in those children aged 24 to 59 months who have claims associated with immunosuppressive conditions. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• Evaluate the rate of FluMist use and the rate of vaccination with other influenza vaccines in children aged 24 to 59 months from the general population [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]

• Describe the demographics of those children aged less than 24 months who receive FluMist or other influenza vaccines [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• Describe demographics and disease characteristics of those children 24- to 59-month old with a claims-based diagnosis of asthma or dispensed medication for wheezing. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
• For each of the cohorts, describe all hospitalizations or emergency room (ER) visits occurring within 42 days following vaccination. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: Yes ]
• Event of special interest include:Primary diagnoses asso.with an ER visit/ hospitalization related to lower resp. disease or infection(for those <24mos.-asthma-wheezing),infections known to exacerbate-wheezing and those with immunosuppressing conditions. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: Yes ]

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

• 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

Children < 60 months of age.

• Asthma
• Wheezing
• Immunosuppression

• 1
  Children less than 24 months of age
• 2
  Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
• 3
  Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
• 4
  Children 24-59 months of age with immunosuppression

• 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.