Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in Europeans Toddlers
Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in Europeans Toddlers
Primary Objective:

 To demonstrate:

 -  the non-inferiority of the seroprotection rate (antibody titers ≥ 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 is
 demonstrated, then

 -  the non-inferiority of the antibody response (geometric mean titers [GMT]). If this
 non-inferiority is demonstrated, then

 -  the superiority of the antibody response (GMT).If this superiority is 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 rSBA. If this non-inferiority is demonstrated, then

 -  the non-inferiority of the antibody response (GMT). If this non-inferiority is
 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 serum bactericidal assay using baby rabbit complement (rSBA). If this
 non-inferiority is demonstrated, then

 -  the non-inferiority of the antibody response (GMT). If this non-inferiority is
 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 is demonstrated, then

 -  the non-inferiority of the antibody response (GMT). If this non-inferiority is
 demonstrated, then

 -  the superiority of the antibody response (GMT) .
Study duration per participant will be 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 includes solicited reactions within 7 days after vaccination, unsolicited
 adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) and
 adverse event of special interest (AESI) throughout the study.
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) has been signed and dated by the parent(s) / legally
 acceptable representative(s) and by an independent witness if required by local
 regulations

 -  Subject and parent / legally acceptable representative are able to attend all
 scheduled visits and to comply 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 may be received at least 2 weeks before or after study vaccines. This exception
 includes 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, subjects with persistent complement deficiency, with anatomic or
 functional asplenia, or subjects 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 (GBS).

 -  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, is 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 C). A prospective subject
 should not be included in the study until the condition has resolved or the febrile
 event has 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 is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.