Clinical trial NCT00626808: A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
Official title: A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Wheezing
Immunosuppression
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: RTI International
First posted: 2008-02-29
Enrollment: 321697
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \< 60 months of age.

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 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

Eligibility 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.

Primary outcomes:
measure: FluMist Use in Participants up to 59 Months of Age
timeFrame: 2009-2010
measure: Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
timeFrame: 2009-2010
measure: Vaccinating Physician Specialty: General/Family Practitioner
timeFrame: 2009-2010
measure: Vaccinating Physician Specialty: Other
timeFrame: 2009-2010
measure: Vaccinating Physician Specialty: Unknown
timeFrame: 2009-2010
measure: Geographic Region: Northeastern
timeFrame: 2009-2010
measure: Geographic Region: North Central
timeFrame: 2009-2010
measure: Geographic Region: Southern
timeFrame: 2009-2010
measure: Geographic Region: Western
timeFrame: 2009-2010
measure: Number of Outpatient Visits: 0
timeFrame: 2009-2010
measure: Number of Outpatient Visits: 1
timeFrame: 2009-2010
measure: Number of Outpatient Visits: 2 or More
timeFrame: 2009-2010
measure: Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
timeFrame: 2009-2010
measure: Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
timeFrame: 2009-2010
measure: Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
timeFrame: 2009-2010
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle
country: United States
facility: Research Site
state: North Carolina
Study officials:
affiliation: MedImmune LLC
name: Chris Ambrose, M.D.
role: STUDY_DIRECTOR
References: