Clinical Trial: Study of a Flu Vaccine in Children

This study is no longer recruiting patients.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Aviron
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This study tests the safety and effectiveness of a flu vaccine in school children. School children are usually the first members of a community to come down with the flu, and they often give the flu to their younger siblings, parents, and grandparents. It is hoped that giving school children a flu vaccine can help prevent the spread of the flu to other members of the community.

Condition Treatment or Intervention Phase
Influenza
 Vaccine: Influenza virus vaccine (CAIV-T)
Phase III

MedlinePlus related topics:  Influenza

Study Type: Interventional
Study Design: Prevention, Open Label

Official Title: Study of the Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in a Community-Based, Non-Randomized, Open-Label Trial in Children to Assess Safety and Herd Immunity for the Control of Epidemic Influenza

Further Study Details: 

Expected Total Enrollment:  15000

This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.

Eligibility

Ages Eligible for Study:  18 Months   -   18 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Your child may be eligible for this study if he/she:

  • Is between the ages of 18 months and 18 years, with consent of parent or guardian.
  • Is a resident of the Temple-Belton, Texas area.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

  • Has had a fever within 3 days before vaccination.
  • Has symptoms of a weakened immune system.
  • Has had a wheezing episode within the past 2 weeks.
  • Has moderate to severe asthma.
  • Is allergic to eggs.
  • Needs to take aspirin on a regular basis.
  • Has received another vaccine or study drug in the past month.

Location Information


Texas
      Pedro A. Piedra, M.D., Houston,  Texas,  77030,  United States

More Information

Study ID Numbers:  DMID 99-021; AV012
Record last reviewed:  March 2002
Last Updated:  October 13, 2004
Record first received:  January 17, 2000
ClinicalTrials.gov Identifier:  NCT00001127
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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