Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or Concomitantly with Two Other Vaccines in Healthy Adolescents

INTERVENTION: Product Name: MenACYW Conjugate Vaccine Product Code: 395 Pharmaceutical Form: Solution for injection INN or Proposed INN: Neisseria Meningitidis Serogroup A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20‐ INN or Proposed INN: Neisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein Other descriptive name: NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT) Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20‐ INN or Proposed INN: Neisseria Meningitidis Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein Other descriptive name: NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20‐ INN or Proposed INN: Neisseria Meningitidis Serogroup W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein Other descriptive name: NEISSERIA MENINGITIDIS GROUP W‐135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20‐ Trade Name: Nimenrix Product Name: Nimenrix Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Neisseria Meningitidis Group A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Concentration unit: µg/ CONDITION: Meningococcal infection ; MedDRA version: 20.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To demonstrate the non‐inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer = 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of MenACYW conjugate vaccine (Group 1) compared to a single dose of Nimenrix® (Group 2) Primary end point(s): Seroprotection against meningococcal serogroups A, C, W, and Y: Group 1 and Group 2 ; Antibody titers measured by hSBA in Groups 1 and 2; Seroprotection defined as antibody titer equal or greater than (=) 1:8 Secondary Objective: To describe:; ‐ the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9‐valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis ‐ inactivated polio vaccine [adsorbed, reduced antigen(s) content] (Tdap‐IPV) vaccines (Group 3); ‐ the antibody response against antigens of 9vHPV and Tdap‐IPV vaccines, before and 1 month following vaccination; ‐ the safety profile in each group after each and any vaccination Timepoint(s) of evaluation of this end point: Day 31 INCLUSION CRITERIA: ‐ Aged 10 to 17 years on the day of inclusion (“10 to 17 years” means from the day of the 10th birthday to the day before the 18th birthday) ‐ Meningococcal C conjugate (MenC) naïve participants or participants having received monovalent MenC priming in infancy (< 2 years of age) ‐ Assent form has been signed and dated by the participant, and informed consent form has been signed and dated by the parent/ legally acceptable representative ‐ Participants and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures ‐ Covered by health insurance, if required by local regulations Are the trial subjects under 18? yes Number of subjects for this age range: 464 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range SECONDARY OUTCOME: Secondary end point(s): 1 ‐ Antibody titers against meningococcal serogroups A, C, W, and Y ; Antibody titers measured by hSBA in each group; 2 ‐ Antibodies titers against antigens contained in Tdap‐IPV vaccine: Group 1 and Group 2 ; Anti‐Polio 1, 2, and 3 antibody titers measured in Group 1 and Group 2; 3 ‐ Antibodies titers against antigens contained in Tdap‐IPV vaccine: Group 3 ; Anti‐Polio 1, 2, and 3 antibody titers measured in Group 3; 4 ‐ Antibodies concentrations against antigens contained in Tdap‐IPV vaccine: Group 1 and Group 2 ; Anti‐tetanus, anti‐diphtheria and anti‐pertussis antibody concentrations measured in Group 1 and Group 2; 5 ‐ Antibodies concentrations against antigens contained in Tdap‐IPV vaccine: Group 3 ; Anti‐tetanus, anti‐diphtheria and anti‐pertussis antibody concentrations measured in Group 3; 6 ‐ Antibodies titers against antigens contained in HPV vaccine: Group 1 and Group 2 ; Anti‐HPV antibody titers measured in Group 1 and Group 2; 7 ‐ Antibodies titers against antigens contained in HPV vaccine: Group 3 ; Anti‐HPV antibody titers measured in Group 3; 8 ‐ Number of participants reporting immediate adverse events (AEs) ; Unsolicited systemic AEs reported in the 30 minutes after each vaccination; 9 ‐ Number of participants reporting solicited injection site reactions and systemic reactions ; Solicited (prelisted in the participant’s diary card and [electronic] Case Report Form [CRF]) injection site and systemic reactions starting any time from the day of vaccination through 7 days after each vaccination; Injection site reactions: pain, erythema and swelling; Systemic reactions: fever, headache, malaise, myalgia; 10 ‐ Number of participants reporting unsolicited non‐serious AEs ; Unsolicited (recorded in a diary card) non‐serious AEs reported up to 30 days after each vaccination; 11 ‐ Number of participants reporting serious adverse events (SAEs) ; Serious adverse events (SAEs) (including adverse events of special interest [AESIs]) reported throughout the study, i.e., from Day 01 (first vaccination) to the last study day (Day 61 for Groups 1 and 2 and Day 31 for Group 3) Timepoint(s) of evaluation of this end point: 1, 3, 5, 7 : Day 01 (pre‐vaccination) and Day 31 (post‐vaccination); 2, 4, 6 : Day 31 (pre‐vaccination) and Day 61 (post‐vaccination); 8 : Within 30 minutes post‐vaccination; 9 : Within 7 days post‐vaccination; 10 : Within 30 days post‐vaccination; 11 : Up to Day 61 post‐vaccination