NCT00197288CompletedPhase 3
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.
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,847
- Locations
- 15
- Primary Endpoint
- Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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 .
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Secondary Outcomes
- Immuno comparison of Fluarix vs Fluzone post-vacc in immunologically -competent, -compromised, overall, stratified by age
- Safety comparison (sol local, general & unsol AEs, SAEs)
- Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)
Investigators
Study Sites (15)
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