Study of a Flu Vaccine in Children

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00001127

Enrollment

15000

Registered

2001-08-31

Start date

Unknown

Completion date

2005-11-30

Last updated

2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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.

Interventions

BIOLOGICALInfluenza virus vaccine (CAIV-T)

Study design

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Months to 18 Years

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026