NCT00001127
Completed
Phase 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)1 site in 1 country15,000 target enrollmentAugust 31, 2001
ConditionsInfluenza
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 15000
- Locations
- 1
- Status
- Completed
- Last Updated
- 15 years ago
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
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