Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program

Study Overview
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Brief Summary
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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 families.

Official Title
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A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program

Conditions
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Influenza

Intervention / Treatment
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* Biological: FluMist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children enrolled in the target schools. Written informed consent obtained from the child's parent(s) if they agree to participate. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>FluMist | Biological: FluMist<br>* 0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the families of children in the target schools with families of children in the control schools with respect to workdays lost by adults and school days lost by children. |  | 7 days after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absenteeism - To compare the families of children in the target schools to those in the control schools with respect to the overall increase in absenteeism during the influenza outbreak, using aggregated (summary) absentee rates. |  | between outbreak and non-outbreak weeks | 
| Herd Community - To compare unvaccinated children in the target schools to the children in the control schools with respect to changes in absentee rates between outbreak weeks and non-outbreak weeks. |  | between outbreak and non-outbreak weeks |