Comparison Of The Safety And Immunogenicity Of A Novel Quadrivalent Meningococcal Acwy-Tetanus Toxoid Conjugate Vaccine And A Marketed Quadrivalent Meningococcal Acwy-Diphtheria Toxoid Conjugate Vaccine In Healthy Individuals 10-25 Years Of Age

Background. Universal immunization of adolescents against meningococcal disease with a quadrivalent meningococcal ACWY (MenACWY) conjugate vaccine is recommended in a number of countries.Methods. In a randomized, controlled, observer-blinded, multicenter trial, 1016 participants, 10-25 years of age, were randomly allocated 1: 1: 1 to receive a single dose of 1 of 2 lots of an investigational tetanus toxoid-conjugated MenACWY vaccine (MenACWY-TT) or a marketed diphtheria toxoid-conjugated MenACWY vaccine (MenACWY-DT). The primary outcome was the noninferiority of the vaccine response after MenACWY-TT (lot A) compared with MenACWY-DT for all 4 serogroups. Vaccine response was defined as a postvaccination human serum bactericidal antibody (hSBA) titer against each of the serogroups of at least 1: 8 in persons initially seronegative (< 1: 4) or as a 4-fold increase in titer pre- to postvaccination in persons initially seropositive (>= 1: 4). Adverse events (AEs) after immunization were measured 4 and 31 days postvaccination.Results. The mean age of participants was 16.3 years; 977 (96.6%) completed the study. The noninferiority of MenACWY-TT (lot A) to the control vaccine in terms of the percentage of participants with hSBA vaccine response was demonstrated for each serogroup. Vaccine response rates ranged from 51.0% to 82.5% for the 4 serogroups after MenACWY-TT (both lots) compared with 39.0%-76.3% for the 4 serogroups after MenACWY-DT. Pain was the most common injection-site reaction reported by 50.8%-55.4% across the 3 groups. Fatigue and headache were the most common systemic solicited AEs, reported by 27.3%-29.2% and 25.5%-26.4%, respectively.Conclusions. Tetanus toxoid-conjugated MenACWY vaccine was well tolerated and elicited an immune response that was noninferior to that of a marketed MenACWY-DT (www.clinicaltrials.gov NCT01165242).