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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

September 12, 2005
September 19, 2008
October 2004
April 2005   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00192218 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program
A Phase IV Study to Evaluate the Effectiveness of Flumist (Influenza Vaccine, Live Intranasal) Vaccination in a School-Based Intervention Program

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: FluMist
0.5 ml of vaccine intranasally (0.25 ml in each nostril) which contains approximately 107 TCID50 of each type
Experimental: 1
FluMist
Intervention: Biological: FluMist
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3022
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
5 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00192218
MI-MA004
Not Provided
Robert Walker, MD, MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Robert Walker, MD MedImmune LLC
MedImmune LLC
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP