Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

Completed · Phase 3

Conditions studied: Influenza

In brief

The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.

Key facts

Study ID

NCT00197288

Run by

GlaxoSmithKline

People needed

1847

Starts

2005-10-01

Expected to finish

2006-06-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All adults 18 years and older.
• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions .

You may not qualify if…

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
• Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• History of hypersensitivity to a previous dose of influenza vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
• Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F)).
• History of Guillain Barré syndrome within 6 weeks of prior receipt of inactivated influenza virus vaccine.
• Pregnancy and lactating females.

Where it is running

• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Evansville, Indiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Buffalo, New York, United States
• GSK Investigational Site — Poughkeepsie, New York, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Carnegie, Pennsylvania, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Warwick, Rhode Island, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — Katy, Texas, United States
• GSK Investigational Site — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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