An investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12-23-month-old children.

Author(s): Knuf M, Pantazi-Chatzikonstantinou A, Pfletschinger U, Tichmann-Schumann I, Maurer H, Maurer L, Fischbach T, Zinke H, Pankow-Culot H, Papaevangelou V, Bianco V, Van der Wielen M, Miller JM

Affiliation(s): Pediatrics Infectious Diseases, University Medicine, Mainz, Germany. markus.knuf@hsk-wiesbaden.de

Publication date & source: 2011-06-06, Vaccine., 29(25):4264-73. Epub 2011 Mar 21.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with DTaP-HBV-IPV/Hib was assessed in a randomized trial in 793 children aged 12-23 months. Pre-specified criteria for non-inferiority of immunogenicity following co-administration versus separate ACWY-TT and DTaP-HBV-IPV/Hib administration were reached. One month post-vaccination, >/= 97.3% of ACWY-TT vaccinees had rSBA titres >/= 1:8 (all serogroups). Seroprotection/seropositivity rates against DTaP-HBV-IPV/Hib antigens were >/= 98.2%. The safety profile of co-administration was similar to that of DTaP-HBV-IPV/Hib alone. ACWY-TT and DTaP-HBV-IPV/Hib co-administration during the second year would facilitate introduction of ACWY-TT into routine toddler vaccination schedules. Copyright (c) 2011 Elsevier Ltd. All rights reserved.