A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals influenza candidate vaccine containing the adjuvant AS25 (FluAS25) in an elderly population aged over 65 years (>65 years-old) previously vaccinated in 2004 with the same candidate vaccine in FLUAS25-001 clinical trial. For immunogenicity and safety evaluations, Fluarix™ (known as alpha-Rix™ in Belgium)vaccine will be used as reference. - FLUAS25-002

GlaxoSmithKline Biologicals0 sites100 target enrollmentOctober 4, 2005

Overview

No summary available.

Registry

who.int

Start Date

October 4, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•All subjects must satisfy the following criteria at study entry:
•1\. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards) should be enrolled in the study.
•2\. Written informed consent obtained from the subject.
•3\. Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
•In the FluAS25 group, all subjects must satisfy the following criteria at study entry:
•\- A male or female aged over 65 years (\> 65 years\-old) at the time of the revaccination; who previously received AS25 adjuvanted influenza vaccine during the FLUAS25\-001 clinical trial.
•In the control group (Fluarix), all subjects must satisfy the following criteria at study entry:
•\- A male or female aged over 65 years (\> 65 years\-old) at the time of revaccination; who previously received Fluarix™ during the FLUAS25\-001 clinical trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Use of any investigational or non\-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
•2\. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, \> or equal 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•3\. History of confirmed influenza infection since a year from the date of previous vaccination.
•4\. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•5\. History of hypersensivity to vaccines.
•6\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•7\. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•8\. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
•9\. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.