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Completed

NCT Number: NCT00192218

Study to Evaluate the Effectiveness of FluMist 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of General Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FluMist

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Sep 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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