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Completed

NCT Number: NCT00626808

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunosuppression Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Research Triangle Park, North Carolina, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

No intervention

Drug

There were no interventions. No subjects were enrolled in this retrospective database study.

Primary outcomes

  1. FluMist Use in Participants up to 59 Months of Age

    Time frame: 2009-2010

    Among participants up to 59 months of age who received any flu vaccine, number who received FluMist

  2. Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist

    Time frame: 2009-2010

    Specialty of vaccinating physician who provided FluMist.

  3. Vaccinating Physician Specialty: General/Family Practitioner

    Time frame: 2009-2010

    Specialty of vaccinating physician who provided FluMist

  4. Vaccinating Physician Specialty: Other

    Time frame: 2009-2010

    Specialty of vaccinating physician who provided FluMist

  5. Vaccinating Physician Specialty: Unknown

    Time frame: 2009-2010

    Specialty of vaccinating physician who provided FluMist

  6. Geographic Region: Northeastern

    Time frame: 2009-2010

    Geographic region of parents' residence among participants receiving FluMist

  7. Geographic Region: North Central

    Time frame: 2009-2010

    Geographic region of parents' residence among participants receiving FluMist

  8. Geographic Region: Southern

    Time frame: 2009-2010

    Geographic region of parents' residence among participants receiving FluMist

  9. Geographic Region: Western

    Time frame: 2009-2010

    Geographic region of parents' residence among participants receiving FluMist

  10. Number of Outpatient Visits: 0

    Time frame: 2009-2010

    Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination

  11. Number of Outpatient Visits: 1

    Time frame: 2009-2010

    Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination

  12. Number of Outpatient Visits: 2 or More

    Time frame: 2009-2010

    Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination

  13. Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0

    Time frame: 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.

  14. Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1

    Time frame: 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.

  15. Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • RTI International

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 29, 2008
Registry last updated
Aug 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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