At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of a Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
In Brief
A Phase 3 clinical trial evaluating Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) and Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningococcal Immunisation (Healthy Volunteers). Completed, enrolled 360 participants across 4 sites.
Detailed Summary
Primary 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 Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Study Details
Timeline
Interventions
Pharmaceutical form: Liquid solution Route of administration: IM
Pharmaceutical form: Liquid solution Route of administration: IM