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

Study Overview
=================
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

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

Conditions
-----------------
Asthma, Wheezing, Immunosuppression

Intervention / Treatment
-----------------
* Drug: No Intervention


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Children less than 24 months of age | Drug: No Intervention<br>* There were no interventions. No subjects were enrolled in this retrospective database study.<br>|
| 2<br>Children 24 to 59 months of age with a claim associated with a diagnosis of asthma | Drug: No Intervention<br>* There were no interventions. No subjects were enrolled in this retrospective database study.<br>|
| 3<br>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<br>* There were no interventions. No subjects were enrolled in this retrospective database study.<br>|
| 4<br>Children 24-59 months of age with immunosuppression | Drug: No Intervention<br>* There were no interventions. No subjects were enrolled in this retrospective database study.<br>|

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 |