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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192218
• Other study ID #: MI-MA004
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 19, 2008
• Start date: October 2004
• Est. completion date: April 2005

Study information

• Verified date: September 2008
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3022
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• FluMist
0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type

Locations

Country	Name	City	State
United States	Division of General Pediatrics, University of Maryland School of Medicine	Baltimore	Maryland
United States	Division of Allergy and Infectious Diseases, University of Washington School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No