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

This study has been completed.
Sponsor:
Collaborator:
RTI International
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00626808
First received: February 20, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Asthma
Wheezing
Immunosuppression
Drug: No Intervention
Phase 4

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 Less Than 5 Years of Age

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • FluMist Use in Participants up to 59 Months of Age [ Time Frame: 2009-2010 ] [ Designated as safety issue: Yes ]
    Among participants up to 59 months of age who received any flu vaccine, number who received FluMist

  • Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Specialty of vaccinating physician who provided FluMist.

  • Vaccinating Physician Specialty: General/Family Practitioner [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Specialty of vaccinating physician who provided FluMist

  • Vaccinating Physician Specialty: Other [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Specialty of vaccinating physician who provided FluMist

  • Vaccinating Physician Specialty: Unknown [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Specialty of vaccinating physician who provided FluMist

  • Geographic Region: Northeastern [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Geographic region of parents' residence among participants receiving FluMist

  • Geographic Region: North Central [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Geographic region of parents' residence among participants receiving FluMist

  • Geographic Region: Southern [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Geographic region of parents' residence among participants receiving FluMist

  • Geographic Region: Western [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Geographic region of parents' residence among participants receiving FluMist

  • Number of Outpatient Visits: 0 [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination

  • Number of Outpatient Visits: 1 [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination

  • Number of Outpatient Visits: 2 or More [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination

  • Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0 [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    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.

  • Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1 [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    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.

  • Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More [ Time Frame: 2009-2010 ] [ Designated as safety issue: No ]
    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.


Enrollment: 321697
Study Start Date: October 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Children less than 24 months of age
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
3
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
There were no interventions. No subjects were enrolled in this retrospective database study.
4
Children 24-59 months of age with immunosuppression
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Research Site
Research Triangle, North Carolina, United States
Sponsors and Collaborators
MedImmune LLC
RTI International
Investigators
Study Director: Chris Ambrose, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00626808     History of Changes
Other Study ID Numbers: MI-MA175
Study First Received: February 20, 2008
Results First Received: July 21, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014