Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

Last updated: January 16, 2017
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Influenza

Treatment

N/A

Clinical Study ID

NCT00197288
104437
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All adults 18 years and older.

  • Subjects who the investigator believes can and will comply with the requirements ofthe 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. eithersurgically sterilized or one year post-menopausal; or, if of childbearing potential,she must be abstinent or have used adequate contraceptive precautions .

Exclusion

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 dayspreceding the administration of the study vaccine, or planned use during the studyperiod.

  • 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 thevaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicinsulphate, thimerosal or sodium deoxycholate.

  • Acute disease at the time of enrollment. (Acute disease is defined as the presence ofa moderate or severe illness with or without fever. All vaccines can be administeredto persons with a minor illness such as diarrhea, mild upper respiratory infectionwith 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 inactivatedinfluenza virus vaccine.

  • Pregnancy and lactating females.

Study Design

Total Participants: 1847
Study Start date:
October 01, 2005
Estimated Completion Date:
June 30, 2006

Study Description

  • Experimental design: multi-center, randomized (1:1), observer-blind, active-controlled study in 2 parallel groups with approximately:

  • Study vaccine: full dose of Fluarix by IM administration.

  • Control vaccine: full dose of Fluzone by IM administration.

  • Two scheduled visits per subject at days 0 (visit 1) and 21(visit 2) with blood sample collected at each visit to evaluate the immune response. There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion.

  • Vaccination schedule: one IM injection at day 0.

  • Type of study: Self contained.

Connect with a study center

  • GSK Investigational Site

    Clearwater, Florida 33761
    United States

    Site Not Available

  • GSK Investigational Site

    Evansville, Indiana 47714
    United States

    Site Not Available

  • GSK Investigational Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • GSK Investigational Site

    Buffalo, New York 14209
    United States

    Site Not Available

  • GSK Investigational Site

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • GSK Investigational Site

    Carnegie, Pennsylvania 15106
    United States

    Site Not Available

  • GSK Investigational Site

    Erie, Pennsylvania 16506
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • GSK Investigational Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77030
    United States

    Site Not Available

  • GSK Investigational Site

    Katy, Texas 77450
    United States

    Site Not Available

  • GSK Investigational Site

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

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