title: Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults.
abstract: This study evaluated the safety, tolerability, and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects received either MenACWY-CRM and Tdap, MenACWY-CRM and saline placebo, or Tdap and saline placebo. No significant increase in reactogenicity and no clinically significant vaccine-related adverse events (AEs) occurred when MenACWY-CRM and Tdap were administered concomitantly. Similar immunogenic responses to diphtheria, tetanus, and meningococcal (serogroups A, C, W-135, and Y) antigens were observed, regardless of concomitant vaccine administration. Antipertussis antibody responses were comparable between vaccine groups for filamentous hemagglutinin and were slightly lower, although not clinically significantly, for pertussis toxoid and pertactin when the two vaccines were administered concomitantly. These results indicate that the investigational MenACWY-CRM vaccine is well tolerated and immunogenic and that it can be coadministered with Tdap to adolescents and young adults.
authors.affiliation: Department of Health Sciences, University of Genoa, Via Pastore 1, 16132 Genoa, Italy. gasparini@unige.it
authors.forename: Roberto
authors.initials: R
authors.lastname: Gasparini
authors.forename: Michele
authors.initials: M
authors.lastname: Conversano
authors.forename: Gianni
authors.initials: G
authors.lastname: Bona
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gabutti
authors.forename: Alessandra
authors.initials: A
authors.lastname: Anemona
authors.forename: Peter M
authors.initials: PM
authors.lastname: Dull
authors.forename: Francesca
authors.initials: F
authors.lastname: Ceddia
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D010919:Placebos / Q000008:administration & dosage; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; C525703:MenACWY; D022401:Meningococcal Vaccines; D010919:Placebos; D018074:Vaccines, Conjugate