Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 20, 2008
July 21, 2014
October 2007
March 2010   (final data collection date for primary outcome measure)
  • 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.
Percentage that received a FluMist immunization [ Time Frame: during the observation period of August through February ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00626808 on ClinicalTrials.gov Archive Site
Not Provided
Percentage that received an influenza vaccine other than FluMist [ Time Frame: during the observation period of August through February ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age

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

  • 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
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Children < 60 months of age.

  • Asthma
  • Wheezing
  • Immunosuppression
Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
  • 1
    Children less than 24 months of age
    Intervention: Drug: No Intervention
  • 2
    Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
    Intervention: Drug: No Intervention
  • 3
    Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
    Intervention: Drug: No Intervention
  • 4
    Children 24-59 months of age with immunosuppression
    Intervention: Drug: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321697
March 2010
March 2010   (final data collection date for primary outcome measure)
  • 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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00626808
MI-MA175
No
MedImmune LLC
MedImmune LLC
RTI International
Study Director: Chris Ambrose, M.D. MedImmune LLC
MedImmune LLC
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP