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

MedImmune LLC2 sites in 1 country3,022 target enrollmentOctober 2004

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: MedImmune LLC
Enrollment: 3022
Locations: 2
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 families.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

April 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedImmune LLC

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 7 days after each vaccination

Secondary Outcomes

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)