Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol
- A male or female between, and including, 18 and 60 years of age at the time of the
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- If the subject is female, she must be of non-childbearing potential; or, if of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions for two
months after completion of the vaccination series.
- Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or
4 weeks (for live vaccines) prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol during the
following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4
weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or
Month 6 + 51 days for the control groups).
- Previous vaccination with a pandemic candidate vaccine or a vaccine containing the
same adjuvant as the study vaccine.
- Previous proven contact with H5N1 wild type virus (i.e. contact with an individual
with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry)
which died as a result of H5N1 infection).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first administration of the
- Any confirmed or suspected immunosuppressive or immunodeficient condition, or
autoimmune diseases such as Guillain Barre Syndrome, based on medical history and
physical examination (no laboratory testing required).
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of
- History of chronic alcohol consumption and/or drug abuse.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
abnormality, as determined by physical examination or laboratory screening tests.
- Serious chronic disease including any medically significant chronic pulmonary,
cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined
by medical history and physical examination.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first administration of the candidate vaccine or during the study.
- Lactating women.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) 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.