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)
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      Study duration per participant was approximately 6 months including: 1 day of screening and
      vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety
      follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration,
      respectively.

      Safety assessment included solicited reactions within 7 days after vaccination, unsolicited
      adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs)
      throughout the study.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological
Intervention description(s): 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
Other intervention name(s): Trumenba®; Bexsero®
Intervention MeSH terms: Vaccines
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)
Primary purpose: Prevention