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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
Results First Received: July 21, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Asthma
Wheezing
Immunosuppression
Intervention: Drug: No Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a retrospective descriptive cohort study of participants up to 59 months of age included in a large medical insurance claims database. Participants up to 59 months of age were screened for vaccination with FluMist or TIV as part of routine clinical practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
Participants Less Than 24 Months of Age Participants less than 24 months of age
Participants 24-59 Months of Age With Asthma Participants 24-59 months of age with a claim associated with a diagnosis of asthma
Participants 24-59 Months of Age With Wheezing Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
Participants 24-59 Months of Age With Immunosuppression Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids

Participant Flow:   Overall Study
    Participants Less Than 24 Months of Age     Participants 24-59 Months of Age With Asthma     Participants 24-59 Months of Age With Wheezing     Participants 24-59 Months of Age With Immunosuppression  
STARTED     254464     34316     30011     2906  
COMPLETED     254464     34316     30011     2906  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Participants Less Than 24 Months of Age Participants less than 24 months of age
Participants 24-59 Months of Age With Asthma Participants 24-59 months of age with a claim associated with a diagnosis of asthma
Participants 24-59 Months of Age With Wheezing Participants 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
Participants 24-59 Months of Age With Immunosuppression Participants 24-59 months of age who had claims associated with any of the following: transplantation, congenital immune deficiency, symptomatic human immunodeficiency virus, hematologic/lymphatic malignancy; immunosuppressive therapy other than systemic corticosteroids within the previous 16 weeks; systemic corticosteroids
Total Total of all reporting groups

Baseline Measures
    Participants Less Than 24 Months of Age     Participants 24-59 Months of Age With Asthma     Participants 24-59 Months of Age With Wheezing     Participants 24-59 Months of Age With Immunosuppression     Total  
Number of Participants  
[units: participants]
  254464     34316     30011     2906     321697  
Age, Customized  
[units: children]
         
< 24 months     254464     0     0     0     254464  
>= 24 months     0     34316     30011     2906     67233  
Gender [1]
[units: participants]
         
Female     NA [3]   NA [3]   NA [3]   NA [3]   NA [2]
Male     NA [3]   NA [3]   NA [3]   NA [3]   NA [2]
[1] Gender was not collected for this database study.
[2] Total not calculated because data are not available (NA) in one or more arms.
[3] Gender was not collected from database.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FluMist Use in Participants up to 59 Months of Age   [ Time Frame: 2009-2010 ]

2.  Primary:   Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist   [ Time Frame: 2009-2010 ]

3.  Primary:   Vaccinating Physician Specialty: General/Family Practitioner   [ Time Frame: 2009-2010 ]

4.  Primary:   Vaccinating Physician Specialty: Other   [ Time Frame: 2009-2010 ]

5.  Primary:   Vaccinating Physician Specialty: Unknown   [ Time Frame: 2009-2010 ]

6.  Primary:   Geographic Region: Northeastern   [ Time Frame: 2009-2010 ]

7.  Primary:   Geographic Region: North Central   [ Time Frame: 2009-2010 ]

8.  Primary:   Geographic Region: Southern   [ Time Frame: 2009-2010 ]

9.  Primary:   Geographic Region: Western   [ Time Frame: 2009-2010 ]

10.  Primary:   Number of Outpatient Visits: 0   [ Time Frame: 2009-2010 ]

11.  Primary:   Number of Outpatient Visits: 1   [ Time Frame: 2009-2010 ]

12.  Primary:   Number of Outpatient Visits: 2 or More   [ Time Frame: 2009-2010 ]

13.  Primary:   Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0   [ Time Frame: 2009-2010 ]

14.  Primary:   Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1   [ Time Frame: 2009-2010 ]

15.  Primary:   Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More   [ Time Frame: 2009-2010 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chris Ambrose
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: ambrosec@medimmune.com


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