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Clinical Trials/NCT00001127
NCT00001127
Completed
Phase 3

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

National Institute of Allergy and Infectious Diseases (NIAID)1 site in 1 country15,000 target enrollmentAugust 31, 2001
ConditionsInfluenza

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Influenza
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment
15000
Locations
1
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
November 2005
Last Updated
15 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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