Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

Completed · Phase 3

Conditions studied: Influenza

In brief

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Key facts

Study ID

NCT00383123

Run by

GlaxoSmithKline

People needed

3327

Starts

2006-11-02

Expected to finish

2007-10-19

Last updated by the study team

2018-06-08

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
• Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
• Female subjects of childbearing potential must agree to take a pregnancy test.

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrollment.
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Pregnant or lactating female.
• Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Where it is running

• GSK Investigational Site — Antioch, California, United States
• GSK Investigational Site — Fairfield, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Pleasanton, California, United States
• GSK Investigational Site — Redwood City, California, United States
• GSK Investigational Site — Richmond, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Santa Rosa, California, United States
• GSK Investigational Site — Vacaville, California, United States
• GSK Investigational Site — Vallejo, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Englewood, Colorado, United States
• GSK Investigational Site — Lakewood, Colorado, United States
• GSK Investigational Site — Tifton, Georgia, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Whitehouse Station, New Jersey, United States
• GSK Investigational Site — Fishkill, New York, United States
• GSK Investigational Site — Hopewell Junction, New York, United States

Full record on ClinicalTrials.gov

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