Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines - Article Avian flu; Bird flu; Bird flu (avian influenza); H5N1
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
|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.
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.
Accepts Healthy Volunteers
"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)).
• Pregnancy and lactating females. "
Location and Contact Information
Clearwater, Florida, 33761, United States
Evansville, Indiana, 47714, United States
Baltimore, Maryland, 21201, United States
St. Louis, Missouri, 36110, United States
Buffalo, New York, 14209, United States
Poughkeepsie, New York, 12601, United States
Cicinnati, Ohio, 45229, United States
Pittsburgh, Pennsylvania, 15236, United States
Philadelphia, Pennsylvania, 19097, United States
Erie, Pennsylvania, 16506, United States
Warwick, Rhode Island, 02886, United States
Houston, Texas, 77030, United States
Katy, Texas, 77450, United States
Marshfield, Wisconsin, 54449, United States
Clinical Trials, Study Director, GlaxoSmithKline
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