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NCT00001127 Clinical Trial

Study of a Flu Vaccine in Children

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001127
Other study ID # DMID 99-021
Secondary ID AV012
Status Completed
Phase Phase 3
First received January 17, 2000
Last updated August 26, 2010
Est. completion date November 2005

Study information
Verified date November 2005
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 15000
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Months to 18 Years
Eligibility 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.

Study Design

Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza virus vaccine (CAIV-T)

Locations
Country Name City State
United States Pedro A. Piedra, M.D. Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Aviron

Country where clinical trial is conducted

United States, 

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