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Study of a Flu Vaccine in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001127
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
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 Intervention Phase
Influenza Biological: Influenza virus vaccine (CAIV-T) Phase 3

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Prevention
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00001127     History of Changes
Other Study ID Numbers: DMID 99-021
AV012
First Submitted: January 17, 2000
First Posted: August 31, 2001
Last Update Posted: August 27, 2010
Last Verified: November 2005

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs