Journal Article

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

Pfletschinger, Ulrich, Knuf, Markus, Fischbach, Thomas, Bianco, Veronique, Van der Wielen, Marie, Maurer, Hartwig, Pankow-Culot, Heidemarie, Tichmann-Schumann, Irmingard, Maurer, Lothar, Miller, Jacqueline M., Pantazi-Chatzikonstantinou, Anna, Zinke, Henrike, Papaevangelou, Vassiliki

2011

Overview

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.

• Publisher: Elsevier Ltd,Elsevier
• Subject: Allergy and Immunology / Antibodies, Bacterial - blood / Antibodies, Viral - blood / antigens / Applied microbiology / Bactericidal activity / Bacteriology / Biological and medical sciences / children / Conjugate vaccine / Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage / Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects / Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology / DTaP-HBV-IPV/Hib combination vaccine / Female / Fundamental and applied biological sciences. Psychology / Haemophilus Vaccines - administration & dosage / Haemophilus Vaccines - adverse effects / Haemophilus Vaccines - immunology / Hexavalent vaccine / Humans / immune response / Infant / Male / Meningococcal Vaccines - administration & dosage / Meningococcal Vaccines - adverse effects / Meningococcal Vaccines - immunology / Microbiology / Miscellaneous / Neisseria meningitidis / Poliovirus Vaccine, Inactivated - administration & dosage / Poliovirus Vaccine, Inactivated - adverse effects / Poliovirus Vaccine, Inactivated - immunology / risk / seroprevalence / serotypes / Tetanus Toxoid - administration & dosage / Tetanus Toxoid - adverse effects / Tetanus Toxoid - immunology / Tetravalent meningococcal vaccine / vaccination / vaccines / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) / Vaccines, Combined - administration & dosage / Vaccines, Combined - adverse effects / Vaccines, Combined - immunology / Vaccines, Conjugate - administration & dosage / Vaccines, Conjugate - adverse effects / Vaccines, Conjugate - immunology / Virology