Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal ABCWY Vaccine; Meningococcal B Recombinant vaccine
Intervention description: Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY_ 0_2 Group, ABCWY_ 0_2_6 Group and ABCWY_ 0_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.; Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B_0_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve 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: 604.0
Sex: All
Minimum age: 12 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: meningococcal disease; meningitis; booster; antibody persistence

Summary:

      The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY
      vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at
      approximately 24 months after the last meningococcal vaccination in the parent study
      V102_15(NCT02212457), compared with baseline antibody levels in vaccine naïve subjects at
      similar age at enrolment.
    

Eligibility criteria:

        Inclusion Criteria:

        Follow-on Participants

          -  Subjects from Finland and Poland previously enrolled in study V102_15 (NCT02212457)
             who have received all planned meningococcal vaccinations in the study

          -  Who have not received any additional meningococcal vaccination since the last
             meningococcal vaccination administered in the parent trial.

          -  Who have given written informed consent or assent after the nature of the study has
             been explained according to local regulatory requirements, prior to study entry. If
             the subject is under age 18 at the time of enrollment, the parent(s)/ legal
             guardian(s) of the subject should have given their written consent.

          -  Individuals of who the investigator believes can and will comply with the requirements
             of the protocol.

          -  Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

        Naive Group

          -  Male and female individuals of similar age (approximately 12-20 years) to follow-on
             subjects from V102_15 (NCT02212457) trial.

          -  Who have not received any meningococcal vaccination since birth

          -  Individuals who have given their written informed consent or assent after the nature
             of the study has been explained according to local regulatory requirements, prior to
             study entry. If the subject is under age 18 at the time of enrollment, the parent(s)/
             legal guardian(s) of the subject should have given their written consent.

          -  Individuals of who the investigator believes can and will comply with the requirements
             of the protocol.

          -  Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

        Exclusion Criteria:

        Follow-on Participants:

          -  Follow-on individuals not eligible to be enrolled in the study are those with:

          -  History of any meningococcal vaccine administration since last meningococcal
             vaccination administered in V102_15 (NCT02212457) parent study.

          -  Current or previous, confirmed or suspected disease caused by N. meningitidis, since
             termination from parent study.

          -  Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days of enrollment.

          -  If the subject is female of childbearing potential, sexually active, and has not used
             any of the acceptable contraceptive methods for at least 2 months prior to study entry
             and for the duration of the trial.

          -  Pregnancy or breast-feeding

          -  History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component including diphtheria toxoid (CRM197) and latex.

          -  Progressive, unstable or uncontrolled clinical conditions.

          -  Any confirmed or suspected condition with impaired/altered function of immune system.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             three months prior to the study vaccination or planned use throughout the study
             period. (For corticosteroids, this means prednisone, or equivalent, ≥ 20 mg/day.
             Inhaled, intranasal and topical steroids are allowed).

          -  Administration of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation in the 3 months prior to study enrolment.

          -  Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent.

          -  Administration of any vaccine within 14 days or 28 days prior to enrollment in the
             study, or within 7 days after vaccination in the study.

          -  Clinical conditions representing a contraindication to intramuscular vaccination
             and/or blood draws.

          -  Who have received systemic antibiotic treatment within 3 days prior to any blood draw

          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study.

        Naive Individuals

          -  Naive individuals not eligible to be enrolled in the study are those with:

          -  History of any meningococcal vaccine administration since birth.

          -  Current or previous, confirmed or suspected disease caused by N. meningitidis.

          -  Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days of enrollment.

          -  If the subject is female of childbearing potential, sexually active, and has not used
             any of the acceptable contraceptive methods for at least 2 months prior to study entry
             and for the duration of the trial.

          -  Pregnancy or breast-feeding.

          -  History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component including diphtheria toxoid (CRM197) and latex.

          -  Progressive, unstable or uncontrolled clinical conditions.

          -  Any confirmed or suspected condition with impaired/altered function of immune system.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within 30
             days prior to the study enrolment. (For corticosteroids, this means prednisone, or
             equivalent, ≥ 20 mg/kg/day. Inhaled, intranasal and topical steroids are allowed).

          -  Administration of blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation in the past 3 months or planned use throughout the study
             period.

          -  Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent.

          -  Individuals who are part of study personnel or close family members conducting this
             study.

          -  Administration of any vaccine within 14 days or 28 days prior to enrollment in the
             study, or within 7 days after first vaccination, and/or planned use of any vaccine 7
             days prior to and 7 days after second vaccination.

          -  Clinical conditions representing a contraindication to intramuscular vaccination
             and/or blood draws.

          -  Who have received systemic antibiotic treatment within 3 days prior to any blood draw

          -  Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study.