Influenza
Conditions
Keywords
Prophylaxis: Influenza virus infection
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.
Interventions
BIOLOGICALInfluenza
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United States
Outcome results
None listed