Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
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
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate
      vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide
      Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US)
      and Puerto Rico.

      Primary objective:

      - To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups
      A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine
      compared to that observed following the administration of a single dose of MENVEO® in
      children aged 2 to 9 years.

      Secondary objectives:

        -  To compare the serum bactericidal assay using human complement (hSBA) antibody geometric
           mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the
           administration of MenACYW Conjugate vaccine to those observed following the
           administration of MENVEO® in children 2 to 9 years of age.

        -  To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following
           the administration of MenACYW Conjugate vaccine and those observed following the
           administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years
           of age, respectively.

        -  To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W
           before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in
           children 6 to 9 years of age, respectively.

      Observational objective:

      - To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed
      MENVEO®.
    

Detailed description: 
      Healthy children were randomized and received a single dose of either MenACYW Conjugate
      vaccine or MENVEO®. They were assessed for immunogenicity at baseline (pre-vaccination) and
      at 30-44 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; Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 milliliter (mL), Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): MenACYW Conjugate vaccine; MENVEO®
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; MENVEO®