Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers
Condition: Meningococcal Immunisation (Healthy Volunteers)
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate:

        -  the non-inferiority of the seroprotection rate (antibody titers greater than or equal to
           [>=] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate
           or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If
           this non-inferiority was demonstrated, then

        -  the non-inferiority of the antibody response (geometric mean titers [GMT]). If this
           non-inferiority was demonstrated, then

        -  the superiority of the antibody response (GMT). If this superiority was demonstrated,
           then

        -  the superiority of the seroprotection rate.

      Or to demonstrate:

        -  the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal
           serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured
           by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority
           was demonstrated, then

        -  the non-inferiority of the antibody response (GMT). If this non-inferiority was
           demonstrated, then

        -  the superiority of the antibody response (GMT).

      Secondary Objective:

      To demonstrate:

        -  the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal
           serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as
           measured by rSBA. If this non-inferiority was demonstrated, then

        -  the non-inferiority of the antibody response (GMT). If this non-inferiority was
           demonstrated, then

        -  the superiority of the antibody response (GMT).

      Or to demonstrate:

        -  the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal
           serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as
           measured by hSBA. If this non-inferiority was demonstrated, then

        -  the non-inferiority of the antibody response (GMT). If this non-inferiority was
           demonstrated, then

        -  the superiority of the antibody response (GMT) .
    

Detailed description: 
      Study duration per participant was approximately 30 days including: 1 day of screening and
      vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after
      vaccine administration, respectively.

      Safety assessment included solicited reactions within 7 days after vaccination, unsolicited
      adverse events up to 30 days after vaccination, serious adverse events and adverse event of
      special interest throughout the study.
    

Intervention name(s): Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine; Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine; Meningococcal group C polysaccharide Conjugate vaccine adsorbed
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular; Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other intervention name(s): MenACYW Conjugate vaccine; Nimenrix®; NeisVac-C®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention