Immunization against influenza in male and female subjects aged 66 years and older.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who were previously vaccinated with GlaxoSmithKline Biologicals Fluarix™ or FluAS25 vaccines in the FluAS25-004 study. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, reporting by phone) should be enrolled in the study. A male or female aged between 19 and 42 years or 66 years and 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 evaluation (medical history and medical history directed examination) before entering into the study. If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. 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 vaccines within 30 days prior to vaccination, or planned use during the study period. Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination. Planned administration of an influenza vaccine other than the study vaccines during the entire study period. Vaccination against influenza since January 2007 with the Northern Hemisphere 2007/2008 influenza vaccine or 2006/2007 influenza vaccine. History of confirmed influenza infection since the date of previous vaccination. 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 or more. Inhaled and topical steroids are allowed.) 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 allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, gentamicin sulphate, thiomersal or sodium deoxycholate and adjuvant AS25 (containing squalene, alpha-tocopherol, Tween 80 and MPL). Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Oral temperature of <37.5°C). Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study. Any medical conditions in which intramuscular injections are contraindicated. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions.
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 (19-42 years) and elderly (=66 years) adults will be used as reference.;Secondary Objective: To evaluate the humoral immune response (anti-haemagglutinin antibody titers) and cell-mediated immune response (production of IFN-?, IL-2, CD40L, and TNF-a), 21 days after re-vaccination with FluAS25. Fluarix™ will be used as reference.;Primary end point(s): Occurrence, intensity, duration 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, in each group. Occurrence, intensity, duration and relationship to vaccination of unsolicited AEs during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination, in each group. Occurrence, intensity, duration and relationship to vaccination of medically significant conditions prompting emergency room visits, hospitalizations or physician visits and that are not routine visits for physical examination or vaccination, during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination, in each group. Occurrence and relationship to vaccination of serious adverse events during the entire study period, in each group. | — |
Countries
Belgium
Outcome results
None listed