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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FluMist
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts 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

Sites / Locations

  • Division of General Pediatrics, University of Maryland School of Medicine
  • Division of Allergy and Infectious Diseases, University of Washington School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

FluMist

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 12, 2005
Last Updated
September 19, 2008
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00192218
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3022 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
FluMist
Intervention Type
Biological
Intervention Name(s)
FluMist
Intervention Description
0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Time Frame
between outbreak and non-outbreak weeks
Title
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.
Time Frame
between outbreak and non-outbreak weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Walker, MD
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Division of General Pediatrics, University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Division of Allergy and Infectious Diseases, University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17167135
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.
Results Reference
derived

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

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