A Post Marking Study to Evaluate the Safety of FluMist in Children
Study identifier:MI-MA162
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
Medical condition
Healthy
Phase
Phase 4
Healthy volunteers
Yes
Study drug
-
Sex
All
Actual Enrollment
29296
Study type
Observational
Age
24 Months - 59 Months
Date
Study Start Date: 01 Oct 2007
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verification:
Verified 01 Mar 2012 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 2 TIV | Biological/Vaccine: TIV (Injection) One or two injections of TIV depending on previous status. |
| Active Comparator: 1 FluMist | Biological/Vaccine: FLuMist One or two vaccinations with FluMist depending on prior vaccination status. |
| No Intervention: 3 Unvaccinated | Other: Unvaccinated Control no vaccine |
Contacts
Investigators
Principal Investigator
Seth Toback
MedImmune Inc.
