Immunisation against influenza disease in elderly population aged over 65 years (>65 years)
Conditions
Interventions
Product Name: Prophylactic Fluarix adjuvanted with AS25
Product Code: FLUAS25
Pharmaceutical Form: Suspension for injection
Other descriptive name: HA from A/New Caledonia/20/99
Concentration unit: µg
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: F.1.2 Adults (18-64 years) no 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of a revaccination with adjuvanted vaccine FluAS25 during 21 days following the intramuscular administration of the vaccine. Fluarix will be used as reference. ;Secondary Objective: To evaluate the humoral immune response (anti-haemagglutinin and anti-MPL titres) and cell mediated immune response (production of IFN-gamma, IL-2, CD40L, and TNF-alpha and B-memory cell response) 21 days after revaccination with adjuvanted influenza vaccine FluAS25. Fluarix will be used as reference.;Primary end point(s): 1. Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination and overall. 2. Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21 day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination and overall. 3. Occurrence of serious adverse events during the entire study. | — |
Countries
Belgium
Outcome results
None listed