A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals AS25 adjuvanted influenza vaccine (FluAS25) in elderly adults previously vaccinated in FluAS25-002 clinical trial with the same candidate vaccine. Fluarix™ will be used as a reference - FluAS25-014

GlaxoSmithKline Biologicals0 个研究点开始时间: 2006年10月11日最近更新: 2014年10月7日

适应症

试验速览

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•- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
•- Written informed consent obtained from the subject.
•- Healthy subjects as established by medical history and clinical examination before entering into the study.
•In the FluAS25 group, all subjects must satisfy the following criteria at study entry:
•- A male or female aged 67 years or above at the time of the revaccination, who previously received FluAS25 during the FluAS25-002 clinical trial.
•In the Fluarix groups, all subjects must satisfy the following criteria at study entry:
•- A male or female aged over 65 years at the time of revaccination; who previously received Fluarix during the FluAS25-002 clinical trial.
•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) 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. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•- History of confirmed influenza infection since the date of previous vaccination.
•- 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 allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thiomersal, gentamicin sulfate or sodium deoxycholate.
•- Acute or chronic 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 vaccination or planned administration during the study period.

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