Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Influenza (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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.
Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Secondary outcome: Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age Safety comparison (sol local, general & unsol AEs, SAEs)
Detailed 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. "
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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. "
Locations and Contacts
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
Additional Information
Starting date: April 2005
Last updated: December 18, 2006
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