Immunization against influenza in healthy male and female subjects aged 65 years and older.
Conditions
Interventions
Product Name: GlaxoSmithKline Biologicals influenza vaccine adjuvanted with AS25
Product Code: FluAS25
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Haemagglutinin from A/New Caledo
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 65 years or 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. 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 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 Visit 2 after vaccination. •Planned administration of an influenza vaccine other than the study vaccines during the entire study period. •Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine). •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.) •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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <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 IM injections are contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the immunological non-inferiority (in terms of HI antibody GMT) of the one container presentation of the AS25 adjuvanted influenza vaccine from the NH 2006/07 season (FluAS25 -1 container NH 2006/07) versus the two container presentation of the AS25 adjuvanted influenza vaccine from the NH 2006/07 season (FluAS25 -2 containers NH 2006/07) 21 days after vaccination in elderly subjects of 65 years and older. To demonstrate the immunological non-inferiority (in terms of HI antibody GMT) of the one-container presentation of the AS25 adjuvanted influenza vaccine from the NH 2007/08 season (FluAS25 -1 container NH 2007/08) versus the two-container presentation of the AS25 adjuvanted influenza vaccine from the NH2007/08 season (FluAS25 -2 containers NH 2007/08), 21 days after vaccination in elderly subjects 65 years and older. ;Secondary Objective: To evaluate the immunogenicity (in terms of HI antibody GMT) of FluAS25 - 1 container NH 2006/07 compared to NH 2007/08, and of FluAS25 - 2 container NH 2006/07 compared to NH 2007/08, 21 days after vaccination in elderly subjects of 65 years and older. To evaluate the immunogenicity (in terms of HI antibody GMT) of FluAS25 - 1 container and FluAS25 -2 containers compared to Fluarix, for the NH 2006/07 season and for the NH 2007/08 season, 21 days after vaccination in elderly subjects of 65 years and older. To assess the immunogenicity (GMT, seroconversion factor, seroconversion rate and seroprotection rate) of FluAS25- 1 container, FluAS25- 2 containers and Fluarix, from each season, 21 days after vaccination in elderly subjects of 65 years and older. To assess the safety and reactogenicity in subjects of 65 years and older vaccinated with FluAS25- 1 container, FluAS25- 2 containers and Fluarix, from each season, during the entire study period. ;Primary end point(s): •At days 0 and 21, serum haemagglutination-inhibition (HI) antibody titer, against the A/New Caledonia (H1N1) vaccine strain, in the | — |
Countries
Denmark, Estonia
Outcome results
None listed