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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626808
• Other study ID #: MI-MA175
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2008
• Last updated: July 21, 2014
• Start date: October 2007
• Est. completion date: March 2010

Study information

• Verified date: July 2014
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321697
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Immunosuppression
• Wheezing

Intervention

Drug:
• No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.

Locations

Country	Name	City	State
United States	Research Site	Research Triangle	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist	Specialty of vaccinating physician who provided FluMist.	2009-2010	No
Primary	Vaccinating Physician Specialty: General/Family Practitioner	Specialty of vaccinating physician who provided FluMist	2009-2010	No
Primary	Vaccinating Physician Specialty: Other	Specialty of vaccinating physician who provided FluMist	2009-2010	No
Primary	Vaccinating Physician Specialty: Unknown	Specialty of vaccinating physician who provided FluMist	2009-2010	No
Primary	Geographic Region: Northeastern	Geographic region of parents' residence among participants receiving FluMist	2009-2010	No
Primary	Geographic Region: North Central	Geographic region of parents' residence among participants receiving FluMist	2009-2010	No
Primary	Geographic Region: Southern	Geographic region of parents' residence among participants receiving FluMist	2009-2010	No
Primary	Geographic Region: Western	Geographic region of parents' residence among participants receiving FluMist	2009-2010	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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