Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine

Exclusion Criteria

• •Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
• •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• •Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
• •Previous vaccination with a vaccine containing NTHi antigens.
• •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. Topical steroids are allowed.
• •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• •Laboratory evidence of clinically significant haematological (complete blood cell count \[Red Blood Cells (RBC), White Blood Cells (WBC)\], WBC differential count, platelets count and haemoglobin level) and biochemical (Alanine Aminotransferase \[ALT\], Aspartate Aminotransferase \[AST\], creatinine and lactate dehydrogenase \[LDH\]) abnormalities as per the opinion of the investigator based on the local laboratory normative data.
• •Acute disease and/or fever at the time of enrolment.
• •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• •History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
• •Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
• •Pregnant or lactating female.
• •Female planning to become pregnant or planning to discontinue contraceptive precautions.
• •History of chronic alcohol consumption and/or drug abuse.
• •Any other condition that the investigator judges may interfere with study findings.