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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192218
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2008
Information provided by:
MedImmune LLC

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: FluMist Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3022 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program
Study Start Date : October 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 1
Biological: FluMist
0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192218

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United States, Maryland
Division of General Pediatrics, University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Washington
Division of Allergy and Infectious Diseases, University of Washington School of Medicine
Seattle, Washington, United States, 98108
Sponsors and Collaborators
MedImmune LLC
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Study Director: Robert Walker, MD MedImmune LLC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert Walker, MD, MedImmune LLC Identifier: NCT00192218    
Other Study ID Numbers: MI-MA004
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 22, 2008
Last Verified: September 2008
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases