NCT00001127CompletedPhase 3
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
National Institute of Allergy and Infectious Diseases (NIAID)2 sites in 1 country15,000 target enrollmentStarted: August 31, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 15,000
- Locations
- 2
Study Overview
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 Design
- Study Type
- Interventional
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Investigators
Study Sites (2)
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