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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626808
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
RTI International
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date February 20, 2008
First Posted Date February 29, 2008
Results First Submitted Date July 21, 2014
Results First Posted Date August 12, 2014
Last Update Posted Date August 12, 2014
Study Start Date October 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 21, 2014)
  • 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
  • Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist [ Time Frame: 2009-2010 ]
    Specialty of vaccinating physician who provided FluMist.
  • Vaccinating Physician Specialty: General/Family Practitioner [ Time Frame: 2009-2010 ]
    Specialty of vaccinating physician who provided FluMist
  • Vaccinating Physician Specialty: Other [ Time Frame: 2009-2010 ]
    Specialty of vaccinating physician who provided FluMist
  • Vaccinating Physician Specialty: Unknown [ Time Frame: 2009-2010 ]
    Specialty of vaccinating physician who provided FluMist
  • Geographic Region: Northeastern [ Time Frame: 2009-2010 ]
    Geographic region of parents' residence among participants receiving FluMist
  • Geographic Region: North Central [ Time Frame: 2009-2010 ]
    Geographic region of parents' residence among participants receiving FluMist
  • Geographic Region: Southern [ Time Frame: 2009-2010 ]
    Geographic region of parents' residence among participants receiving FluMist
  • Geographic Region: Western [ Time Frame: 2009-2010 ]
    Geographic region of parents' residence among participants receiving FluMist
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: February 20, 2008)
Percentage that received a FluMist immunization [ Time Frame: during the observation period of August through February ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: February 20, 2008)
Percentage that received an influenza vaccine other than FluMist [ Time Frame: during the observation period of August through February ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
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
Brief Summary This is a retrospective cohort study of children included in a large medical insurance claims database.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children < 60 months of age.
Condition
  • Asthma
  • Wheezing
  • Immunosuppression
Intervention Drug: No Intervention
There were no interventions. No subjects were enrolled in this retrospective database study.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2014)
321697
Original Actual Enrollment
 (submitted: February 20, 2008)
0
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00626808
Other Study ID Numbers MI-MA175
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MedImmune LLC
Study Sponsor MedImmune LLC
Collaborators RTI International
Investigators
Study Director: Chris Ambrose, M.D. MedImmune LLC
PRS Account MedImmune LLC
Verification Date July 2014