Study of a Flu Vaccine in Children

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Influenza virus vaccine (CAIV-T)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00001127

AV012

DMID 99-021

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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.