Clinical Trial: Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional



Official Title: Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years

Brief Summary:

The purpose of the study is 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 and to demonstrate the immune 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 vs licensed MCV4 vaccine.

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.
  • 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 licensed MCV4 vaccine.

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 licensed MCV4 vaccine 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 ob