Back to resultsStudy of a Flu Vaccine in Children
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Influenza virus vaccine (CAIV-T)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
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.
Sites / Locations
- Pedro A. Piedra, M.D.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001127
First Posted
January 17, 2000
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Aviron LLC
1. Study Identification
Unique Protocol Identification Number
NCT00001127
Brief Title
Study of a Flu Vaccine in Children
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Aviron LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
15000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (CAIV-T)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pedro A. Piedra, M.D.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of a Flu Vaccine in Children
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