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OpenTrials
Completed

NCT Number: NCT00001127

Study of a Flu Vaccine in Children

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pedro A. Piedra, M.D.

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza virus vaccine (CAIV-T)

Biological

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Aviron LLC

Registry information

Official study 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

Important dates

Study completion
2005
First posted
Aug 31, 2001
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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