A Phase IIb, Randomized, Observer-Blind study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

INTERVENTION: Product Name: combined Meningococcal Groups A, B, C, W and Y vaccine Product Code: MenABCWY Pharmaceutical Form: Powder and suspension for suspension for injection INN or Proposed INN: Recombinant Neisseria meningitidis group B NHBA fusion protein Current Sponsor code: NHBA fusion protein Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Recombinant Neisseria meningitidis group B NadA protein Current Sponsor code: NadA protein Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Recombinant Neisseria meningitidis group B fHbp fusion protein Current Sponsor code: fHbp fusion protein Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ INN or Proposed INN: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 Current Sponsor code: OMV Other descriptive name: OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 25‐ INN or Prop CONDITION: Healthy volunteers (Active immunization against IMD caused by N.meningitidis serogroups A, B, C, W and Y) ; MedDRA version: 20.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] SECONDARY OUTCOME: Secondary end point(s): 1. Percentage of participants with hSBA titers = LLOQ for N. meningitidis serogroups A, C, W and Y ; 2. Percentage of participants with hSBA titers = LLOQ for each N. meningitidis serogroup B indicator strains and for serogroups A, C, W and Y Timepoint(s) of evaluation of this end point: 1. At Baseline (Day 1), 1 month after the first dose of MenABCWY (Day 31) and 1 month after second dose of MenABCWY (Day 751 for the ABCWY‐24 Group and Day 1471 for the ABCWY‐48 Group) ; 2. At 25 months after the second dose of MenABCWY (Day 1471 for the ABCWY‐24 Group) INCLUSION CRITERIA: • Participants 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. • 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) prior to performing any study specific procedure. • A male or female between, and including, 11 and 14 years of age (i.e. 14 years + 364 days) at the time of the first vaccination. • Healthy participants as established by medical history, physical examination and clinical judgment of the investigator before entering into 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, PRIMARY OUTCOME: Main Objective: Immunogenicity:; • To assess the immune response to 2 doses of the MenABCWY vaccine administered on a 0‐ and 24‐month schedule, and a 0‐ and 48‐month schedule against Neisseria meningitidis (N. meningitidis) serogroup B indicator strains; Safety:; • To evaluate the safety and reactogenicity of the MenABCWY vaccine; Primary end point(s): 1. Percentage of participants with human serum bactericidal assay (hSBA) titers = lower limit of quantitation (LLOQ) for each N. meningitidis serogroup B indicator strains ; 2. Percentage of participants with hSBA titers = LLOQ for each N. meningitidis serogroup B indicator strains ; 3. Percentage of participants with solicited administration site events ; 4. Percentage of participants with solicited systemic events ; 5. Percentage of participants with any unsolicited adverse events (AEs) including all serious adverse events (SAEs), AEs leading to withdrawal, adverse events of special interest (AESIs) and medically attended AEs ; 6. Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs; 7. Percentage of participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs Secondary Objective: • To assess the immune response to 1 and 2 doses of the MenABCWY vaccine administered on a 0‐ and 24‐month schedule, and a 0‐ and 48‐month schedule against N. meningitidis serogroups A, C, W and Y; • To evaluate the antibody persistence at 25 months after the second dose of the MenABCWY vaccine administered on a 0‐and 24‐month schedule against N. meningitidis serogroup B indicator strains and serogroups A, C, W and Y; Timepoint(s) of evaluation of this end point: 1. At Baseline (Day 1) ; 2. At 1 month after the second dose of MenABCWY (Day 751 for the ABCWY‐24 Group and Day 1471 for the ABCWY‐48 Group); 3, 4. During the 7 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721, and Day 1441); 5. During the 30 days (including the day of vaccination) following each vaccination (Vaccines administered at Day 1, Day 721 and Day 1441); 6. During the 6 months (including the day of vaccination) following the first vaccination (Vaccine administered at Day 1); 7. During the 6 months (including the day of vaccination) following the second vaccination (Vaccine administered at Day 721)