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

MedImmune

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: FluMist

Study type

Interventional

Funder types

Industry

Identifiers

NCT00192218

MI-MA004

Details and patient eligibility

About

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.

Enrollment

3,022 patients

Sex

All

Ages

5 to 17 years old

Volunteers

Accepts Healthy Volunteers

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