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. - 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 (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. In the FluAS25 group, all subjects must satisfy the following criteria at study entry: - A male or female aged 66 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-003 clinical trial. In the Fluarix Yng and Fluarix Eld groups, all subjects must satisfy the following criteria at study entry: - A male or female aged between, and including, 19 and 41 years of age or over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-003 clinical trial. 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
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 in elderly adults, the safety and reactogenicity of repeated vaccination with FluAS25, during 21 days following the intramuscular administration of the vaccine. Fluarix administered to young (19-41 years) and elderly (>/= 66 years) adults 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 B-memory cells) 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