Clinical trial NCT00192218: Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
Official title: A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 3022
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: 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.
timeFrame: 7 days after each vaccination
Secondary outcomes:
measure: 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.
timeFrame: between outbreak and non-outbreak weeks
measure: 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.
timeFrame: between outbreak and non-outbreak weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Division of General Pediatrics, University of Maryland School of Medicine
state: Maryland
city: Seattle
country: United States
facility: Division of Allergy and Infectious Diseases, University of Washington School of Medicine
state: Washington
Study officials:
affiliation: MedImmune LLC
name: Robert Walker, MD
role: STUDY_DIRECTOR
References:
citation: King JC Jr, Stoddard JJ, Gaglani MJ, Moore KA, Magder L, McClure E, Rubin JD, Englund JA, Neuzil K. Effectiveness of school-based influenza vaccination. N Engl J Med. 2006 Dec 14;355(24):2523-32. doi: 10.1056/NEJMoa055414.