Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

All participants received 1 dose of MenACYW Conjugate vaccine or NIMENRIX® on Day 0 and were evaluated for immunogenicity and safety profile. The duration of each participant's participation in the trial was 30 to 44 days.

Inclusion criteria

• Aged 12 to 23 months on the day of the first study visit.
• Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) or with a birth weight ≥2.5 kilogram (kg) (5.5 pounds).
• Inform Consent Form (ICF) had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
• Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.
• Covered by health insurance where applicable.

Exclusion criteria

• Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccine.
• Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or Conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y.
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
• 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 (≥ 2 milligram [mg]/kg/day of 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 (i.e., 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 trial or to a vaccine containing any of the same substances.
• Known systemic hypersensitivity to latex.
• Known thrombocytopenia, as reported by the parent/legally acceptable representative.
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
• Personal history of Guillain-Barré syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
• 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 (°C). 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.