Immunogenicity and Safety of a Booster Dose 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 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: Double (Participant, Investigator)
Enrollment: 810.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine; Licensed Meningococcal Conjugate Vaccine (MCV4)

Summary:

      The aim of the study was to describe the safety and antibody response to booster
      administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid
      (MenACYW) Conjugate vaccine in participants who received their first quadrivalent
      meningococcal Conjugate vaccine dose in the past 4-10 years.

      Primary Objective:

        -  To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal
           serogroups A, C, Y, and W following the administration of a booster dose of MenACYW
           Conjugate vaccine compared to those observed following the administration of a booster
           dose of Menactra® in participants who were first vaccinated with 1 dose of a
           quadrivalent meningococcal vaccine 4 to 10 years before the booster dose.

      Secondary Objectives:

        -  To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured
           using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after
           vaccination in a subset of 120 participants.

        -  To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W
           measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination.

      Observational Objectives:

        -  To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured
           by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination.

        -  To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before
           and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by
           rabbit serum bactericidal assay (rSBA) in a subset of participants.

        -  To describe the safety profile of MenACYW Conjugate vaccine compared to that of a
           licensed Menactra® after booster vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >= 15 years on the day of inclusion.

          -  Participant has documented record of having received 1 dose of a quadrivalent
             meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.

          -  Participant aged 15 to < 18 years: assent form signed and dated by the participant and
             informed consent form (ICF) signed and dated by the parent or guardian.

          -  Participant aged >=18 years: ICF signed and dated by the participant.

          -  Participants aged 15 to < 18 years: both the participant and parent / guardian were
             able to attend all scheduled visits and to comply with all trial procedures.

          -  Participants aged >= 18 years: able to attend all scheduled visits and to comply with
             all trial procedures.

        Exclusion Criteria:

          -  Participant was pregnant, lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be 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 before Day 30 visit except for influenza vaccination,
             which may be received at least 2 weeks before study investigational vaccines. This
             exception includes monovalent pandemic influenza vaccines and multivalent influenza
             vaccines.

          -  Previous vaccination against meningococcal disease with either an investigational or
             approved 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 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 vaccine(s) used in the trial 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.

          -  Verbal report of 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.

          -  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, is at a stage where it might
             interfere with trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to the Investigator's judgment)
             on the day of vaccination or febrile illness (temperature >= 100.4°Fahrenheit [F]). A
             prospective participant 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 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.