Study of a Flu Vaccine in Children

This study has been completed.

First Received: January 17, 2000 Last Updated: November 11, 2005 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Aviron
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001127

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	Intervention	Phase
Influenza	Biological: Influenza virus vaccine (CAIV-T)	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:	15000
Estimated Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001127

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Aviron

More Information

No publications provided

Study ID Numbers:	DMID 99-021, AV012
Study First Received:	January 17, 2000
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00001127 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on November 22, 2009