Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants

Inclusion Criteria

• Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
• Available for all the visits scheduled in the study.
• In good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

• History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
• Previous known or suspected disease caused by N. meningitidis.
• Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
• History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
• Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
• Immune deficiency disorder, or known HIV infection.
• Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
• History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
• History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
• Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
• Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
• Family members or household members of site research staff.
• Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
• History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.