Study of a Flu Vaccine in Children - Tabular View

Tracking Information
First Received Date ^ICMJE	January 17, 2000
Last Updated Date	November 11, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of a Flu Vaccine in Children
Official Title ^ICMJE	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
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Open Label
Condition ^ICMJE	Influenza
Intervention ^ICMJE	Biological: Influenza virus vaccine (CAIV-T)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15000
Completion Date	November 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Months to 18 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001127
Responsible Party
Study ID Numbers ^ICMJE	DMID 99-021, AV012
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE	Aviron
Investigators ^ICMJE
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP