Study of a Flu Vaccine in Children
Phase 3
Completed
- Conditions
- Influenza
- Registration Number
- NCT00001127
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15000
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pedro A. Piedra, M.D.
🇺🇸Houston, Texas, United States