A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults (=66 years) previously vaccinated in the FluAS25-004 clinical trial with the same candidate vaccine. Fluarix™ (known as a-Rix in Belgium) administered in young (19-42 years) and elderly (=66 years) adults will be used as reference. - FluAS25-008 EXT:003 Y2

• Conditions: Immunization against influenza in male and female subjects aged 66 years and older.

• Registration Number: EUCTR2007-002880-29-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-16
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified