Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers
Condition: Meningococcal Immunisation (Healthy Volunteers)
Intervention: 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 description: 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
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Modified double-blind: the participant (or legally acceptable representative), and the Investigator remained unaware of the treatment assignments throughout the study. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
Enrollment: 707.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

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) .
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged 12 to 23 months on the day of the first study visit ("12 to 23 months" means from
             the 12th month after birth to the day before the 24th month after birth).

          -  Informed consent form (ICF) had been signed and dated by the parent(s)/legally
             acceptable representative(s) and by an independent witness if required by local
             regulations.

          -  Participant and parent/legally acceptable representative were able to attend all
             scheduled visits and complied with all trial procedures.

        Exclusion criteria:

          -  Participation in the 4 weeks (28 days) preceding the study vaccination or planned
             participation during the present study period in another clinical study investigating
             a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or
             planned receipt of any vaccine prior to Visit 2 except for influenza vaccination,
             which might be received at least 2 weeks before or after study vaccines. This
             exception included monovalent pandemic influenza vaccines and multivalent influenza
             vaccines.

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal
             vaccine containing serogroups A, C, W, or Y; or meningococcal B vaccine).

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

          -  History of meningococcal infection, confirmed either clinically, serologically, or
             microbiologically

          -  At high risk for meningococcal infection during the trial (specifically, but not
             limited to, participants with persistent complement deficiency, with anatomic or
             functional asplenia, or participants travelling to countries with high endemic or
             epidemic disease).

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccines used in the study or to a vaccine containing
             any of the same substances .

          -  Personal history of an Arthus-like reaction after vaccination with a tetanus
             toxoid-containing vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  Thrombocytopenia, as reported by the parent/ legally acceptable representative or
             suspected thrombocytopenia contraindicating intramuscular vaccination in the
             Investigator's opinion.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination in the Investigator's opinion.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of vaccination or febrile illness (temperature >= 38.0 degree Celsius). A
             prospective participant should not be included in the study until the condition had
             resolved or the febrile event had subsided.

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
             blood draw.

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.