A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Phase 3




Biological: Placebo
Biological: FluarixTM
Biological: GSK's candidate influenza vaccine 1562902A

Study type


Funder types




Details and patient eligibility


This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.




61+ years old


Accepts Healthy Volunteers

Inclusion criteria

  • Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
  • Female subjects of non-childbearing potential.
  • Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
  • Written informed consent obtained from the subject.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion criteria

  • Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
  • Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
  • Previous administration of a pandemic influenza vaccine.
  • Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
  • Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of chronic alcohol consumption and/or drug abuse.
  • History of hypersensitivity to vaccines.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Acute disease and/or fever at the time of enrolment.
  • Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Trial design

Primary purpose




Interventional model

Parallel Assignment


Triple Blind

0 participants in 2 patient groups

Group A
Experimental group
Biological: GSK's candidate influenza vaccine 1562902A
Biological: Placebo
Biological: FluarixTM
Group B
Experimental group
Biological: GSK's candidate influenza vaccine 1562902A
Biological: Placebo
Biological: FluarixTM

Trial contacts and locations



Data sourced from clinicaltrials.gov

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