Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age

Exclusion Criteria

• •Medical conditions
• •Progressive, unstable, or uncontrolled clinical conditions.
• •Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• •Abnormal function of the immune system resulting from:
• •* Clinical conditions.
• •* Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
• •* Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• •History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
• •Current or previous, confirmed, or suspected disease caused by N. meningitidis.
• •Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
• •History of neuroinflammatory or autoimmune condition.
• •Recurrent history or un-controlled neurological disorders or seizures.
• •Prior/Concomitant therapy
• •Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.
• •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.
• •Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
• •Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, Menactra or MenQuadfi).
• •Prior/Concurrent clinical study experience
• •Participant concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled.
• •Other exclusions
• •Child in care.
• •Pregnant or lactating female.
• •Female planning to become pregnant or planning to discontinue contraceptive precautions.
• •Any study personnel or immediate dependents, family, or household member.