A phase III, observer-blind, multi-country, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals FLU NG vaccine compared to the reference vaccine Fluarix™ when administered to elderly subjects aged 66 years and older. - FLU NG-037 EXT:005 Y2

Conditions: Immunization against influenza in male and female subjects aged 66 years or older and 19-43 years of age.

Registration Number: EUCTR2008-002362-66-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1252

Inclusion Criteria

•A male or female subject previously enrolled in study FluAS25-010 in the 65 years or older and 18-41 years of age groups and having received the study vaccine.
•Subjects of whom 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). Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
•Written informed consent obtained from the subject.
•Free of an acute aggravation of the health status 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. 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 vaccination.
Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device or intrauterine system, vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).
For azoospermia, documented” refers to the laboratory report of azoospermia, required for acceptable documentation of successful vasectomy in the subject’s male partner.
Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.

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 2008 with any seasonal 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 hypersensitivity to a previous dose of influenza vaccine.
•History of allergy or reactions likely to be exacerbated by any component of the vaccines.
•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)).
•Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
•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.
•Any medical conditions in which intramuscular injections are contraindicated.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.