Study of a Flu Vaccine in Children
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
2 other identifiers
interventional
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedAugust 27, 2010
November 1, 2005
January 17, 2000
August 26, 2010
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pedro A. Piedra, M.D.
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 17, 2000
First Posted
August 31, 2001
Study Completion
November 1, 2005
Last Updated
August 27, 2010
Record last verified: 2005-11