title: Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants: An Open, Randomized Trial.
abstract: This was the first study evaluating the immunogenicity and safety of the quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) coadministered with routine childhood vaccines in young infants.
  
  
  
  In this open, randomized, controlled, phase III study (NCT01144663), 2095 infants (ages 6-12 weeks) were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age, or MenACWY-TT, MenC-cross-reactive material (CRM197) or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immune responses were measured by serum bactericidal activity assays using rabbit (rSBA) and human (hSBA) complement. Solicited and unsolicited symptoms were recorded during 8 and 31 days post-vaccination, respectively, and serious adverse events throughout the study.
  
  
  
  Noninferiority of immune responses to MenC induced by 2 or 3 doses of MenACWY-TT versus 2 doses of MenC-TT or MenC-CRM197 was demonstrated. Predefined criteria for the immunogenicity of MenACWY-TT to MenA, MenW and MenY were met. One month after 2 or 3 primary MenACWY-TT doses, ≥93.1% and ≥88.5% of infants had rSBA and hSBA titers ≥1:8 for all serogroups. The robust increases in rSBA and hSBA titers observed for all vaccine serogroups postbooster vaccination suggested that MenACWY-TT induced immune memory. MenACWY-TT coadministered with childhood vaccines had a clinically acceptable safety profile.
  
  
  
  This study supports the coadministration of MenACWY-TT with routine childhood vaccines as 2 or 3 primary doses during infancy followed by a booster dose in the second year of life.
authors.affiliation: From the *Pediatrics Department, Hospital Universitario de Burgos, Avenida Islas Baleares, Burgos, Spain; †Instituto Hispalense de Pediatria, C/Jardin de la Isla N° 6, Edificio Expolocal, Sevilla, Spain; ‡Pediatric Office Dr. Horn, Schoenau, Germany; §Manlleu Primary Care Center, Osona, Spain; ¶Pediatrics Department, Hospital La Fe, Valencia, Spain; ‖Institut Pediàtric Marès - Riera, Pediatría, Blanes, Spain; **Pediatrics Department, Rio Hortega University Hospital, Valladolid, Spain; ††Pediatrics Department, Hospital de Antequera, Antequera, Spain; ‡‡Hospital Universitari Germans Trias i Pujol, Badalona, Spain; §§Hospital General Universitario de Ciudad Real, Ciudad Real, Spain; ¶¶Study Center Weilheim, Pediatric Practice Weilheim, Weilheim in Oberbayern, Germany; ‖‖Private Practice Bleckmann, Baunatal, Germany; ***Private Practice Fischbach, North-Rhine, Solingen, Germany; †††GSK Pharmaceuticals, Bangalore, India; ‡‡‡GSK Vaccines, Vaccine Development and Discovery Department, Wavre, Belgium; and §§§GSK Vaccines, Merion, Pennsylvania.
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Merino Arribas
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carmona Martínez
authors.forename: Michael
authors.initials: M
authors.lastname: Horn
authors.forename: Xavier Maria
authors.initials: XM
authors.lastname: Perez Porcuna
authors.forename: Maria Del Carmen
authors.initials: MD
authors.lastname: Otero Reigada
authors.forename: Josep
authors.initials: J
authors.lastname: Marès Bermúdez
authors.forename: Fernando
authors.initials: F
authors.lastname: Centeno Malfaz
authors.forename: Mariano
authors.initials: M
authors.lastname: Miranda
authors.forename: Maria
authors.initials: M
authors.lastname: Mendez
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Garcia Cabezas
authors.forename: Christoph
authors.initials: C
authors.lastname: Wittermann
authors.forename: Gerhard
authors.initials: G
authors.lastname: Bleckmann
authors.forename: Thomas
authors.initials: T
authors.lastname: Fischbach
authors.forename: Devayani
authors.initials: D
authors.lastname: Kolhe
authors.forename: Marie
authors.initials: M
authors.lastname: van der Wielen
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D005060:Europe; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects; D007223:Infant; D008589:Meningococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine