Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
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; Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Intervention description: 0.5 milliliter (mL), Intramuscular; 0.5 mL, 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)
Enrollment: 1000.0
Sex: All
Minimum age: 2 Years
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; MENVEO®

Summary:

      The purpose of the study was to evaluate the immunogenicity and describe the safety of
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate
      vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide
      Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US)
      and Puerto Rico.

      Primary objective:

      - To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups
      A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine
      compared to that observed following the administration of a single dose of MENVEO® in
      children aged 2 to 9 years.

      Secondary objectives:

        -  To compare the serum bactericidal assay using human complement (hSBA) antibody geometric
           mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the
           administration of MenACYW Conjugate vaccine to those observed following the
           administration of MENVEO® in children 2 to 9 years of age.

        -  To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following
           the administration of MenACYW Conjugate vaccine and those observed following the
           administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years
           of age, respectively.

        -  To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W
           before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in
           children 6 to 9 years of age, respectively.

      Observational objective:

      - To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed
      MENVEO®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 2 to 9 years on the day of inclusion.

          -  Assent form had been signed and dated by the participant (as required by local
             regulations) and informed consent form had been signed and dated by parent(s) or
             guardian.

          -  Participant and parent/guardian were able to attend all scheduled visits and complied
             with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination until at least 4 weeks after vaccination. To be considered of
             non-childbearing potential, a female must be pre-menarche.

          -  Participation 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 (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 the study investigational
             vaccines. This exception included monovalent, multivalent, live, and attenuated
             influenza vaccines.

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal
             vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing
             vaccine).

          -  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
             (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 traveling 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.

          -  Verbal report of thrombocytopenia, contraindicating intramuscular vaccination by the
             Investigator's judgment.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination in the Investigator's opinion.

          -  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's judgment) on
             the day of vaccination or febrile illness (temperature ≥100.4°F). 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.