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
Study type: Interventional
Phase: Phase 3

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®.
    

Detailed description: 
      Healthy meningococcal-vaccine naïve adolescents and adults were randomized and received a
      single dose of either MenACYW Conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3)
      or Menactra®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30
      to 44 days post-vaccination. Safety information were collected post-vaccination and
      throughout the entire study.
    

Intervention name(s): 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 type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): MenACYW conjugate vaccine; Menactra®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine; Licensed MCV4 vaccine