Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
Condition: Meningococcal Immunisation (Healthy Volunteers)
Intervention: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine; Meningococcal Group B vaccine (Trumenba®); Meningococcal group B vaccine (Bexsero®)
Intervention description: Pharmaceutical form: Solution for injection Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially-randomized design: all participants primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while participants primed with Menveo vaccine were automatically allocated to Group 2 (not randomized).
Masking: None (Open Label)
Masking description: The laboratory personnel who performed the serology testing were blinded to the group assignment.
Enrollment: 570.0
Sex: All
Minimum age: 13 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and
      W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups
      A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine:

        -  In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate
           vaccine 3-6 years before the booster dose.

        -  In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine
           (meningococcal [Groups A, C, Y and W135] Oligosaccharide Diphtheria CRM197 Conjugate
           vaccine) 3-6 years before the booster dose.

      Secondary Objective:

      To describe:

        -  The vaccine seroresponse, seroprotection (serum bactericidal assay using human
           complement [hSBA] titer greater than or equal to [>=]1:8), and antibody responses
           (geometric mean titers [GMTs]) of meningococcal serogroups A, C, Y, and W measured using
           hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50
           participants per group (Groups 1 and 2).

        -  The vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody responses
           (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination)
           and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and
           2).

        -  The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of
           meningococcal serogroups A, C, Y, and W before a booster dose in participants who
           received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier.

        -  The antibody persistence (GMTs and vaccine seroprotection; hSBA titer >=1:8) of
           meningococcal serogroups A, C, Y, and W in participants who received either a single
           dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or
           Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or
           MET43 (participants randomized to MET59 Groups 1, 3 and 4).

        -  To describe the vaccine seroresponse, seroprotection (hSBA titer >=1:8), and antibody
           responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW
           Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine
           (Groups 3 and 4), compared to those when it was given alone (Group 1).
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged >= 13 to less than (<) 26 years on the day of inclusion.

          -  Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only)
             or study MET43 (MET43 Groups 1, 2, or 3 only).

          -  For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment
             population): participants had a documented record of having received 1 dose of Menveo
             vaccine 3-6 years earlier either as part of a clinical trial or as routine
             vaccination. Participants who participated in MET50 Group 4 can be enrolled if they
             fulfill this criterion.

          -  Participants aged 13 to < 18 years: assent form had been signed and dated by the
             participant and informed consent form (ICF) had been signed and dated by the parent or
             guardian.

          -  Participants aged >=18 (or legal age of majority, if different from 18 years of age)
             to < 26 years: ICF had been signed and dated by the participants.

          -  Participant aged 13 to < 18 years: both the participant and parent or guardian were
             able to attend all scheduled visits and complied with all trial procedures.

          -  Participants aged >=18 (or legal age of majority, if different from 18 years of age)
             to < 26 years: 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 the
             first vaccination until at least 4 weeks after the last vaccination. To be considered
             of non-childbearing potential, a female must be pre-menarche, or post-menopausal for
             at least 1 year, or surgically sterile.

          -  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 Visit 3 (Day 30) except for influenza
             vaccination, which might be received at least 2 weeks before study investigational
             vaccine.

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          -  Receipt of any meningococcal vaccine including a licensed or investigational MenACWY
             vaccine or MenB vaccine since participation in study MET50 or MET43.

          -  Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of
             more than 1 dose of Menveo vaccine or vaccination with another licensed or
             investigational MenACWY vaccine or with a licensed or investigational MenB vaccine.

          -  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 vaccines used in the trial or to a vaccine containing
             any of the same substances.

          -  Personal history of Guillain-Barré syndrome.

          -  Personal history of an Arthus-like reaction after vaccination with a tetanus
             toxoid-containing vaccine within at least 10 years of the proposed study vaccination.

          -  Verbal report of thrombocytopenia, contraindicating IM vaccination.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination.

          -  Current alcohol abuse or drug addiction.

          -  Chronic illness (e.g., Human immunodeficiency viruses, hepatitis B, hepatitis C) 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). 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 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.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.