Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine
Intervention description: 0.5 milliliter (mL), Intramuscular (IM); 0.5 mL, IM
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; NIMENRIX®

Summary:

      The purpose of the study was to evaluate the immunogenicity and safety profile of a single
      dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW)
      Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A,
      C, W 135 and Y (NIMENRIX®) Conjugate vaccine.

      Observational objectives:

        -  To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present
           in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using
           baby rabbit complement (rSBA) and by serum bactericidal assay using human complement
           (hSBA)

        -  To evaluate the antibody responses against tetanus in participants who received MenACYW
           Conjugate vaccine or NIMENRIX® vaccine

        -  To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®
    

Eligibility criteria:

        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.