Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
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 (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention description: 0.5 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: Double (Participant, Investigator)
Enrollment: 3344.0
Sex: All
Minimum age: 10 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine; Licensed MCV4 vaccine

Summary:

      The purpose of the study was to evaluate immune lot consistency of Meningococcal
      Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the
      immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety
      and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55
      years of age in the United States (US).

      Primary Objectives:

        -  To demonstrate the immune lot consistency of the antibody responses to meningococcal
           serogroups A, C, Y, and W following the administration of a single dose of MenACYW
           Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA)
           geometric mean titers (GMTs).

        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups
           A, C, Y, and W following the administration of a single dose of MenACYW Conjugate
           vaccine (pooled Lots 1 to 3) compared to those observed following the administration of
           a single dose of Menactra®.

      Secondary Objective:

        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups
           A, C, Y, and W following the administration of a single dose of MenACYW Conjugate
           vaccine (pooled Lots 1 to 3) compared to those observed following the administration of
           a single dose of Menactra® in the adult population (18 to 55 years old).

        -  To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups
           A, C, Y, and W following the administration of a single dose of MenACYW Conjugate
           vaccine (pooled Lots 1 to 3) compared to those observed following the administration of
           a single dose of Menactra® in the adolescent population (10 to 17 years old).

        -  To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for
           each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination.

        -  To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following
           the administration of MenACYW Conjugate vaccine to those observed following the
           administration of Menactra®.

      Observational Objectives:

        -  To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed
           Menactra®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 10 to 55 years on the day of inclusion.

          -  Informed consent form was signed and dated by the participant (aged 18 to 55 years) or
             assent form was signed and dated by the participant and informed consent form was
             signed and dated by the parent(s) or guardian (for participants aged 10 to < 18
             years).

          -  Participant (>= 18 years) or participant (10 to < 18 years) and parent / guardian were
             able to attend all scheduled visits and comply with all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered
             of non-childbearing potential, a female must have been pre-menarche or post-menopausal
             for at least 1 year, surgically sterile, or using an effective method of contraception
             or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after
             vaccination).

          -  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 may be received at least 2 weeks before or after the study investigational
             vaccines. This exception includes monovalent pandemic influenza vaccines and
             multivalent influenza vaccines.

          -  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, Y, or W; or meningococcal B 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, as reported by the participant or the participant's
             parent / guardian, 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.

          -  Personal history of Guillain-Barre syndrome.

          -  Personal history of an Arthus-like reaction after vaccination with a tetanus
             toxoid-containing vaccine within 10 years of the proposed study vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  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 >= 100.4 degree Fahrenheit [°F]). A
             prospective participant was not be included in the study until the condition was
             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 an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.