Immunisation against influenza disease in an elderly population aged over 65 years
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. - Written informed consent obtained from the subject. - Healthy subjects as established by medical history and 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 67 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-002 clinical trial. In the Fluarix groups, all subjects must satisfy the following criteria at study entry: - A male or female aged over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-002 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: - 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. - 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, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed). - History of confirmed influenza infection since the date of previous vaccination. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). - History of hypersensivity to a previous dose of influenza vaccine. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine 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. - Acute disease at the time of enrolment. - Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of repeated vaccination with 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 antibody titres), cell-mediated immune response (production of IFN, IL-2, CD40L, and TNF) and anti-MPL antibody titres 21 days after revaccination with FluAS25. Fluarix will be used as reference.;Primary end point(s): - 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. - 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. - Occurrence of serious adverse events during the entire study period | — |
Countries
Belgium
Outcome results
None listed