Clinical Trial: Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines

This study is not yet open for patient recruitment.
Verified by GlaxoSmithKline September 2005

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197288

Purpose

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.
Condition Intervention Phase
Prophylaxis: Influenza virus infection
 Vaccine: Influenza
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study

Official Title: A Phase III, Observer-Blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix™ (GlaxoSmithKline Biologicals) Compared with Fluzone® (Aventis Pasteur) Administered Intramuscularly in Adults 18 Years and Older in the U.S.

Further Study Details: 
Primary Outcomes: To demonstrate the immunological non-inferiority (GMT and seroconversion rates) of Fluarix versus Fluzone given intramuscularly in adults (aged 18 years), 21 days following vaccination
Secondary Outcomes: "• To demonstrate the immunological non-inferiority (GMT and seroconversion rates) of Fluarix versus Fluzone given intramuscularly in elderly subjects (aged > 65 years), 21 days following vaccination.; • To compare the immunogenicity of Fluarix versus Fluzone post-vaccination (GMT, seroconversion, seroprotection and proportion with four-fold increase in HI titer if baseline titer is <1:40) in the following groups: immunologically competent, immunologi; • To compare local and general solicited reactogenicity and all unsolicited AEs (non-serious AEs, including new onset chronic illness, and serious AEs) in subjects vaccinated with Fluarix and Fluzone, age-stratified and overall.; "
Expected Total Enrollment:  1820

Study start: October 2005

"• 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. "

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

"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 ." "• 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 hypersensivity 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. "

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00197288

Clinical Coordinator      +1.877.379.37.18 

Florida
      Clearwater,  Florida,  33761,  United States

Indiana
      Evansville,  Indiana,  47714,  United States

Maryland
      Baltimore,  Maryland,  21201,  United States

Missouri
      St. Louis,  Missouri,  36110,  United States

New York
      Buffalo,  New York,  14209,  United States

      Poughkeepsie,  New York,  12601,  United States

Ohio
      Cicinnati,  Ohio,  45229,  United States

Pennsylvania
      Pittsburgh,  Pennsylvania,  15236,  United States

      Philadelphia,  Pennsylvania,  19097,  United States

      Erie,  Pennsylvania,  16506,  United States

Rhode Island
      Warwick,  Rhode Island,  02886,  United States

Texas
      Houston,  Texas,  77030,  United States

      Katy,  Texas,  77450,  United States

Wisconsin
      Marshfield,  Wisconsin,  54449,  United States

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  104437
Last Updated:  September 19, 2005
Record first received:  September 19, 2005
ClinicalTrials.gov Identifier:  NCT00197288
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-20

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