At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care
In Brief
A Phase 3 clinical trial evaluating Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine, Meningococcal group B vaccine, and 3 other interventions for Healthy Volunteers (Meningococcal Infection). Completed, enrolled 788 participants across 13 sites.
Detailed Summary
The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone. The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.
Study Details
Timeline
Interventions
Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL