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

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

Study Overview

• Status: Completed
• Conditions: Asthma; Immunosuppression; Wheezing
• Intervention / Treatment: Drug: No Intervention

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

• Study Type: Observational
• Enrollment (Actual): 321697

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle, North Carolina, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children < 60 months of age.

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Children less than 24 months of age	Drug: No Intervention; There were no interventions. No subjects were enrolled in this retrospective database study.
2; Children 24 to 59 months of age with a claim associated with a diagnosis of asthma	Drug: No Intervention; There were no interventions. No subjects were enrolled in this retrospective database study.
3; Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing	Drug: No Intervention; There were no interventions. No subjects were enrolled in this retrospective database study.
4; Children 24-59 months of age with immunosuppression	Drug: No Intervention; There were no interventions. No subjects were enrolled in this retrospective database study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FluMist Use in Participants up to 59 Months of Age	Among participants up to 59 months of age who received any flu vaccine, number who received FluMist	2009-2010
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist	Specialty of vaccinating physician who provided FluMist.	2009-2010
Vaccinating Physician Specialty: General/Family Practitioner	Specialty of vaccinating physician who provided FluMist	2009-2010
Vaccinating Physician Specialty: Other	Specialty of vaccinating physician who provided FluMist	2009-2010
Vaccinating Physician Specialty: Unknown	Specialty of vaccinating physician who provided FluMist	2009-2010
Geographic Region: Northeastern	Geographic region of parents' residence among participants receiving FluMist	2009-2010
Geographic Region: North Central	Geographic region of parents' residence among participants receiving FluMist	2009-2010
Geographic Region: Southern	Geographic region of parents' residence among participants receiving FluMist	2009-2010
Geographic Region: Western	Geographic region of parents' residence among participants receiving FluMist	2009-2010
Number of Outpatient Visits: 0	Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination	2009-2010
Number of Outpatient Visits: 1	Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination	2009-2010
Number of Outpatient Visits: 2 or More	Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination	2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0	Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.	2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1	Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.	2009-2010
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More	Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.	2009-2010

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: RTI International
• Investigators: Study Director: Chris Ambrose, M.D., MedImmune LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 20, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): August 12, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: MI-MA175