A phase II, controlled, randomized, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly 60 years and older. - FLU-LD-003
- Conditions
- Immunization against influenza in male and female subjects aged 60 years and older.
- Registration Number
- EUCTR2006-002680-18-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A male or female age 60 years or older at the time of the vaccination.
Written informed consent obtained from the subject.
Free of obvious health problems as established by medical history and clinical 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
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screenin tests.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent. 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).
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.
Administration of other licensed vaccines within 30 days prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol during the study period.
History of hypersensivity to a previous dose of influenza vaccine.
Previous vaccination against influenza within the 12 months prior to enrollment.
History of confirmed influenza infection within the last 12 months.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS03 .
Acute disease at the time of enrolment.
History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E) within the last 12 Months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the humoral immune response (anti-haemagglutinin) elicited by the low dose influenza vaccine adjuvanted with AS03 and by Fluarix, with the Northern Hemisphere 2006-2007 influenza vaccine composition, 21 days after vaccination.;Secondary Objective: To assess the cellular mediated immune response elicited by the low dose influenza vaccine adjuvanted with AS03 and by Fluarix™, in terms of Th1-specific cytokine expression (CD40L, IL-2, TNFa, IFNg) after in vitro restimulation of influenza-specific CD4/CD8, 21 days after vaccination.<br><br>To assess the safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 and Fluarix during 30 days following the intramuscular administration of the vaccines in elderly subjects 60 years and over.<br>;Primary end point(s): At days 0 and 21: serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine influenza virus strains, in each group
- Secondary Outcome Measures
Name Time Method