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

Completed

• Conditions: Immunosuppression; Wheezing; Asthma
• Interventions: Drug: No Intervention

• Registration Number: NCT00626808
• Lead Sponsor: MedImmune LLC

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-07
• Results First Submitted: 2014-07-21
• Results First Submitted QC: 2014-07-21
• Last Update Submitted: 2014-07-21
• Results First Posted: 2014-08-12
• Last Update Posted: 2014-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321697

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	No Intervention	Children less than 24 months of age
3	No Intervention	Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
4	No Intervention	Children 24-59 months of age with immunosuppression
2	No Intervention	Children 24 to 59 months of age with a claim associated with a diagnosis of asthma

Primary Outcome Measures

Name	Time	Method
Geographic Region: Western	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0	2009-2010	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.
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist	2009-2010	Specialty of vaccinating physician who provided FluMist.
Number of Outpatient Visits: 1	2009-2010	Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Geographic Region: Northeastern	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Geographic Region: North Central	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 2 or More	2009-2010	Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
FluMist Use in Participants up to 59 Months of Age	2009-2010	Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Vaccinating Physician Specialty: General/Family Practitioner	2009-2010	Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Unknown	2009-2010	Specialty of vaccinating physician who provided FluMist
Geographic Region: Southern	2009-2010	Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 0	2009-2010	Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1	2009-2010	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.
Vaccinating Physician Specialty: Other	2009-2010	Specialty of vaccinating physician who provided FluMist
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More	2009-2010	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Research Triangle, North Carolina, United States