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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192218
First received: September 12, 2005
Last updated: September 19, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention Phase
Influenza
 Biological: FluMist
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by MedImmune LLC:

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. [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: No ]

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. [ Time Frame: between outbreak and non-outbreak weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3022
Study Start Date: October 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FluMist
 Biological: FluMist
0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192218

Locations
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
Investigators
Study Director: Robert Walker, MD MedImmune LLC
  More Information

No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert Walker, MD, MedImmune LLC
ClinicalTrials.gov Identifier: NCT00192218     History of Changes
Other Study ID Numbers: MI-MA004
Study First Received: September 12, 2005
Last Updated: September 19, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013