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Study of a Flu Vaccine in Chi...

Study of a Flu Vaccine in Children

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Influenza virus vaccine (CAIV-T)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes