A Post Marketing Evaluation of the Effectiveness For Use of FluMist Among Children

This study has been completed.
Sponsor:
Collaborator:
RTI International
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00626808
First received: February 20, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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


Condition
Asthma
Wheezing
Immunosuppression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged less than 24 months. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged 24 to 59 months with a claims-based diagnosis of asthma. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • Evaluate the rate of FluMist use and describe the rate of vaccination with other influenza vaccines in children aged 24 to 59 months dispensed medication for wheezing. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • Evaluate the demographics and rate of vaccination with FluMist and other influenza vaccines in those children aged 24 to 59 months who have claims associated with immunosuppressive conditions. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • Evaluate the rate of FluMist use and the rate of vaccination with other influenza vaccines in children aged 24 to 59 months from the general population [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the demographics of those children aged less than 24 months who receive FluMist or other influenza vaccines [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • Describe demographics and disease characteristics of those children 24- to 59-month old with a claims-based diagnosis of asthma or dispensed medication for wheezing. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: No ]
  • For each of the cohorts, describe all hospitalizations or emergency room (ER) visits occurring within 42 days following vaccination. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: Yes ]
  • Event of special interest include:Primary diagnoses asso.with an ER visit/ hospitalization related to lower resp. disease or infection(for those <24mos.-asthma-wheezing),infections known to exacerbate-wheezing and those with immunosuppressing conditions. [ Time Frame: Y 2007-2008 and 2009-2010 season ] [ Designated as safety issue: Yes ]

Enrollment: 316
Study Start Date: August 2007
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Children less than 24 months of age
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
3
Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
4
Children 24-59 months of age with immunosuppression

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

Ages Eligible for Study:   up to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children < 60 months of age.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626808

Locations
United States, North Carolina
RTI Health Solutions
Research Triangle Park, North Carolina, United States, 27709-2194
Sponsors and Collaborators
MedImmune LLC
RTI International
Investigators
Study Director: Seth Toback, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Patricia Tennis, PhD, FISPE, RTI Health Solutions (RTI-HS), RTI
ClinicalTrials.gov Identifier: NCT00626808     History of Changes
Other Study ID Numbers: MI-MA175
Study First Received: February 20, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014