An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years and older) and Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 years) - FLUAS25-003

Conditions: Immunisation against influenza disease in adults aged 18-40 years and elderly population aged over 65 years (>65 years)

Registration Number: EUCTR2005-002360-28-BE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 425

Inclusion Criteria

? Subjects who the investigator believes they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
? A male or female aged 18 years or older at the time of the vaccination.
? Written informed consent obtained from the subject.
? Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the vaccine dose, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > or equal 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•History of administration of an experimental vaccine containing MPL and/or QS21
•History of hypersensitivity to a previous dose of influenza vaccine
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•History of confirmed influenza infection since a year from the date of previous vaccination
•Administration of an influenza vaccine in the year 2005
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the non inferiority 21 days post-vaccination between the influenza adjuvanted vaccines administrated in elderly subjects (aged 65 years and older) and Fluarix™ administered in adults (aged 18-40 years) in terms of frequency of antigen-specific CD4 T-lymphocytes producing at least two different cytokines (CD40L, IL-2, TNF-alpha, IFN-gamma).;Secondary Objective: 1) To evaluate the safety and reactogenicity of vaccination with candidate influenza vaccines adjuvanted with AS25, AS50, AS01B or AS01E<br>2) To evaluate the humoral immune response (anti-haemagglutinin titre) 21, 90 and 180 days after vaccination with influenza cadidate vaccines adjuvanted with AS25, AS50, AS01B or AS01E. <br>;Primary end point(s): At day 21: CMI response in all subjects in terms of frequency of influenza-specific CD4 T-lymphocyte per 106 in tests producing at least two different cytokines (IL-2, IFN-gamma, TNF-alpha and CD40L)

Secondary Outcome Measures