A phase III, observer-blind, multicountry, multicenter, study to evaluate the safety, reactogenicity and immunogenicity, of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine administered intramuscularly in adults aged 65 years and older previously vaccinated in the FluAS25-005 clinical trial with the same candidate vaccine. Fluarix™ administered in adults aged 65 years and older will be used as reference. - FluAS25-010 EXT:005 Y1

Conditions: Immunization against influenza disease in an elderly population aged over 65 years and in adult aged 18-40 years old.

Registration Number: EUCTR2007-002368-83-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1967

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• 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.
• Male or female subjects who participated in the FluAS25-005 study and were
enrolled in the = 65 years age group (received FluAS25 or Fluarix) or in the 18-
40 years age group (received Fluarix).
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

• 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 30 days after vaccination
• Planned administration of an influenza vaccine other than the study vaccines
during the entire study period
• Any vaccination against influenza since January 2007 (with the 2006/2007 or
the 2007/2008 influenza vaccine)
• Chronic administration (defined as more than 14 days) of immunosuppressants
or other immune-modifying drugs within six months prior to the first vaccine
dose. (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,
thimerosal or sodium deoxycholate and adjuvant AS25 (containing squalene, a-
tocopherol, Tween 80 and MPL)
• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by 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 (99.5°F) / Axillary temperature <37.5°C (99.5°F)
• Administration of immunoglobulins and/or any blood products within the three
months preceding the first dose of study vaccine or planned administration during the study period
• 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
• Any medical conditions in which IM injections are contraindicated
• Pregnant or lactating female, or planning to become pregnant or to discontinue
contraceptive precautions.