Status:
COMPLETED
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
Lead Sponsor:
MedImmune LLC
Conditions:
Influenza
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
Brief Summary
To measure the effectiveness of influenza vaccination in school children by comparing, between target(i.e., children are offered FluMist) and control (i.e., children are not offered FluMist) school fa...
Eligibility Criteria
Inclusion
- Healthy children enrolled in the target schools.
- Written informed consent obtained from the child's parent(s) if they agree to participate.
Exclusion
- History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist
- FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions include:
- Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy
- Immunosuppression of child
- Severe immunosuppression of a household member
- Pregnancy
- Past history of Guillian-Barre Syndrome
- Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration
- Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist
- Received anti-influenza medication in the past 48 hours
- Fever in the past 72 hours
- Moderate to severe nasal congestion (inability to breathe through the nose) or acute phase URI symptoms until the congestion has improved
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
3022 Patients enrolled
Trial Details
Trial ID
NCT00192218
Start Date
October 1 2004
End Date
April 1 2005
Last Update
September 22 2008
Active Locations (2)
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1
Division of General Pediatrics, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
2
Division of Allergy and Infectious Diseases, University of Washington School of Medicine
Seattle, Washington, United States, 98108