Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
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As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals' Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 Years &Amp; Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 Years)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To demonstrate the non inferiority 21 d post-vaccination of the influenza adjuvanted vaccines administered in elderly subjects (aged 65 y and older) [ Time Frame: 21 days post vaccination ]
as compared to Fluarix™ administered in adults (aged 18-40 y) in terms of cellular mediated immune response. [ Time Frame: 21 days post vaccination ]
Secondary Outcome Measures :
To evaluate the safety and reactogenicity of vaccination with adjuvanted influenza vaccines during 21 d following the intramuscular administration of the vaccine [ Time Frame: 21 days post vaccination ]
in elderly subjects (aged 65 y and older). Fluarix will be used as reference. [ Time Frame: 21 days post vaccination ]
To evaluate the humoral immune response (anti-haemagglutinin titre) 21,90 and 180d after vaccination with influenza adjuvanted candidate vaccines. [ Time Frame: 21, 90 and 180 days post vaccination ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
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.
History of confirmed influenza infection since a year from the date of previous vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.