A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults

• Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups. [ Time Frame: During a 7-day (day 0-6) follow up period after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups. [ Time Frame: During a 30-day (day 0-29) follow up period after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
• Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 1 day after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 7 days after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 29/30 days after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 6 months after the last vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 12 months after the last vaccine dose ] [ Designated as safety issue: No ]

• Occurrence of solicited local and general Adverse events. (AE) in all subjects, in all vaccine groups. [ Time Frame: During a 7-day follow up period after each vaccine dose. ] [ Designated as safety issue: No ]
• Occurrence of unsolicited AEs in all subjects, in all vaccine groups. [ Time Frame: During a 30-day follow up period after each vaccine dose. ] [ Designated as safety issue: No ]
• Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
• Occurrence of any AE of specific interest in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 1 day after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 7 days after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 29/30 days after each vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 6 months after the last vaccine dose ] [ Designated as safety issue: No ]
• Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 12 months after the last vaccine dose ] [ Designated as safety issue: No ]

• Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose. ] [ Designated as safety issue: No ]
• Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups. [ Time Frame: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540. ] [ Designated as safety issue: No ]

• Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose ] [ Designated as safety issue: No ]
• Colonisation with S. aureus in all subjects, in all vaccine groups. [ Time Frame: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540. ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.

• Biological: Staphylococcal investigational vaccine GSK2392103A
  intramuscular vaccination according to protocol schedule
• Biological: Staphylococcal investigational vaccine GSK2392105A
  intramuscular vaccination according to protocol schedule
• Biological: Staphylococcal investigational vaccine GSK2392106A
  intramuscular vaccination according to protocol schedule
• Biological: Staphylococcal investigational vaccine GSK2392019A
  intramuscular vaccination according to protocol schedule
• Drug: Saline placebo
  intramuscular vaccination according to protocol schedule

• Experimental: Group A
  Not Applicable
  Intervention: Biological: Staphylococcal investigational vaccine GSK2392103A
• Experimental: Group B
  Not Applicable
  Intervention: Biological: Staphylococcal investigational vaccine GSK2392105A
• Experimental: Group C
  Not Applicable
  Intervention: Biological: Staphylococcal investigational vaccine GSK2392106A
• Experimental: Group D
  Not Applicable
  Intervention: Biological: Staphylococcal investigational vaccine GSK2392019A
• Placebo Comparator: Group E
  Not Applicable
  Intervention: Drug: Saline placebo
• Placebo Comparator: Group F
  Not Applicable
  Intervention: Drug: Saline placebo

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test at Screening, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.
• Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.
• History of; or current bleeding or coagulation disorder.
• Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of; or current autoimmune or other immune-mediated disease.
• Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines up to 1 month after the last vaccine dose.
• Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Any clinically relevant abnormal haematological or biochemical or urine laboratory values at screening.
• Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
• Acute disease and/or fever at study entry.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• History of; or current alcoholism and/or drug abuse.
• Any other condition that the principal investigator judges may interfere with study findings.