Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults
The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a
 GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults
 aged between 18 and 60 years.
The protocol posting has been updated to reflect changes due to an amendment to the protocol
 (addition of an exclusion criterion). The Protocol Posting has been updated in order to
 comply with the FDA Amendment Act, Sep 2007.
Inclusion Criteria:

 -  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
 first vaccination.

 -  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.

 Exclusion Criteria:

 -  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
 candidate vaccines.

 -  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
 the vaccine.

 -  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.