A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Withdrawn
Phase 3

Conditions

Influenza

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866580
112865

Details and patient eligibility

About

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

Sex

All

Ages

61+ years old

Volunteers

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

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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