Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
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 the immunogenicity and describe the safety of a
      single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid
      (MenACYW) Conjugate vaccine compared to the licensed Meningococcal polysaccharide groups A,
      C, W-135 and Y (Nimenrix®) Conjugate vaccine in toddlers 12 to 23 months of age in the
      European Union (EU). The toddlers were either meningococcal vaccine naïve or had received
      monovalent meningococcal C (MenC) vaccination during infancy to evaluate any potential impact
      of the meningococcal vaccine background on the immunogenicity and safety profile of the
      investigational product.

      Primary Objectives:

        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups
           A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in toddlers
           who either were meningococcal vaccine naïve or had received monovalent MenC vaccination
           during infancy.

        -  To demonstrate the non-inferiority of the antibody response to meningococcal serogroups
           A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in
           meningococcal vaccine naïve toddlers.

      Secondary Objectives:

        -  To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal
           serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as
           measured by serum bactericidal assay using human complement (hSBA) in toddlers who
           either were meningococcal vaccine naïve or had received monovalent MenC vaccination
           during infancy.

        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W
           after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in
           meningococcal vaccine naïve toddlers.

        -  To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W
           after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in toddlers
           who received monovalent MenC vaccination during infancy.
    

Detailed description: 
      Healthy toddlers were randomized depending on their meningococcal priming vaccination
      background (either meningococcal vaccine naïve or primed with MenC) and received a single
      dose of either MenACYW Conjugate vaccine or Nimenrix®. They were assessed for immunogenicity
      at baseline (pre-vaccination) and 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 polysaccharide groups A, C, W-135 and Y Conjugate vaccine; Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 milliliter (mL), Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): MenACYW Conjugate vaccine; Nimenrix®; MenACYW Conjugate vaccine; Nimenrix®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; Nimenrix®; Menjugate®