Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Condition: Meningococcal Immunisation; Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using
      human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups
      A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide
      (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
      (Group 1) compared to a single dose of Nimenrix® (Group 2).

      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 of meningococcal serogroup C measured by hSBA and serum
           bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31
           after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according
           to MenC primed status.

        -  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.
    

Detailed description: 
      The duration of study participation for each participant was approximately 30 to 60 days,
      including 2 or 3 visits (1 or 2 vaccination visit) and 1 or 2 telephone calls, depending on
      study Group.

      * This was the first dose of 9vHPV, of the 2-dose or 3-dose series according to the local
      recommendations and age of the participant. These additional vaccinations for the completion
      of 9vHPV schedule took place outside of the objectives and scope of this study and thus were
      not described in this protocol.
    

Intervention name(s): Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine); Meningococcal group A, C, W-135, and Y conjugate vaccine; Human Papillomavirus 9-valent Vaccine (9vHPV); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular; Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other intervention name(s): MenQuadfi®; Nimenrix®; Gardasil® 9; Repevax®/Triaxis®/Adacel®Polio
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a parallel group prevention study with 2 groups that were observer blind (only the person administering the vaccine was unblinded), and 1 group that was open-label.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment