Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenABCWY vaccine; rMenB+OMV NZ (Bexsero) vaccine; MenACWY (Menveo) vaccine
Intervention description: Two doses administered intramuscularly in the deltoid region of the non-dominant arm.; Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group, rMenBOMV+ACWY_D Group and rMenBOMV Group; Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group and rMenBOMV+ACWY_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 520.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Concomitantly; Adolescent; Neisseria meningitidis; Healthy subjects; Adult

Summary:

      The purpose of the current study is to evaluate whether there is immune interference when
      MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid
      component] is administered to healthy adolescents and adults following a 2-dose vaccination
      schedule with MenABCWY administered 2 months apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who,
             in the opinion of the investigator, can and will comply, with the requirements of the
             protocol (e.g. completion of the paper diary (pDiary), return for follow-up visits,
             availability for all visits scheduled in the study).

          -  Written informed consent obtained from the subject and/or from the parent(s)/LAR(s) of
             the subject prior to performing any study specific procedure.

          -  Written informed assent obtained from subjects below the legal age of consent prior to
             performing any study specific procedure.

          -  A male or female between, and including, 10 to 25 years of age at the time of the
             first vaccination.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Female subjects 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, or bilateral ovariectomy.

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced highly effective contraception for 30 days prior to vaccination,
                  and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue highly effective contraception during the entire treatment
                  period and for 2 months after completion of the vaccination series.

        Exclusion Criteria:

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions

          -  Pregnant or lactating female

          -  Child in care

          -  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.

          -  Previous vaccination against N. meningitidis at any time prior to informed consent.

          -  Progressive, unstable or uncontrolled clinical conditions.

          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study.

          -  Clinical conditions representing a contraindication to IM vaccination and blood draws.

          -  Abnormal function of the immune system resulting from:

               -  Clinical conditions.

               -  Systemic administration of corticosteroids (oral/intravenous/IM) for more than 14
                  consecutive days within 90 days prior to informed consent.

               -  Administration of antineoplastic and immune modulating agents or radiotherapy
                  within 90 days prior to informed consent.

          -  Received immunoglobulins or any blood products within 180 days prior to informed
             consent.

          -  Received an investigational or non registered medicinal product within 30 days prior
             to informed consent.

          -  Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study.

          -  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.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal
             functional abnormality, as determined by physical examination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Are obese at screening.

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of neuroinflammatory or autoimmune condition.

          -  History of significant neurological disorder or seizure.

          -  Serious chronic illness.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any study personnel as an immediate family or household member.

          -  Administration of a vaccine not foreseen by the study protocol in the period starting
             14 days (for inactivated vaccines), 28 days (for live vaccines), or 7 days (for
             influenza vaccines) before each dose and ending 14 days (for inactivated vaccines), 28
             days (for live vaccines), or 7 days (for influenza vaccines) after each dose of study
             vaccine(s) administration.

          -  Thrombocytopenia, bleeding disorders, or be receiving anticoagulant therapy.