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

A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

Inclusion Criteria:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.

• Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.

• Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.

• Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.

• A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.

• Healthy participants as established by medical history and clinical examination before entering the study.

• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

• Female participants of childbearing potential may be enrolled in the study if the participant:

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

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.