A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
Study identifier:MI-MA175
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
asthma, immunosuppression
Phase
Phase 4
Healthy volunteers
No
Study drug
No Intervention
Sex
All
Actual Enrollment
321697
Study type
Observational
Age
N/A
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Mar 2010
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: -
Verification:
Verified 01 Jul 2014 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
RTI International
Inclusion and exclusion criteria
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No locations available
| Arms | 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. |
Contacts
Investigators
Principal Investigator
Chris Ambrose
MedImmune Inc.
