A dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young children

• Published in: Vaccine Vol. 28; no. 3; pp. 744 - 753
• Main Authors: Knuf, M, Kieninger-Baum, D, Habermehl, P, Muttonen, P, Maurer, H, Vink, P, Poolman, J, Boutriau, D
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 08.01.2010; Elsevier; Elsevier Limited
• Subjects: Allergy and Immunology; Antibodies, Bacterial - blood; Applied microbiology; Bactericidal activity; Bacteriology; Biological and medical sciences; Child, Preschool; Children & youth; Conjugate vaccine; Female; Fundamental and applied biological sciences. Psychology; Humans; Immunization; Immunogenicity; Infant; Male; Meningitis; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Meningococcal Vaccines - immunology; Microbiology; Miscellaneous; Neisseria meningitidis; Teenagers; Tetanus Toxoid - administration & dosage; Tetanus Toxoid - adverse effects; Tetanus Toxoid - immunology; Tetravalent meningococcal vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology; Canada; Australia; United States > US; Germany; Conjugate vaccine; Bactericidal activity; Tetravalent meningococcal vaccine; Human; Toxoid; Neisseriaceae; Neisseria meningitidis; Vaccine; Infection; Immunogenicity; Bacteriosis; Bacteria; Micrococcales; Tetanus; Child
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2009.10.064

Abstract Meningococcal disease incidence is highest in young children, yet a tetravalent conjugate vaccine is currently not available for this age group. This study evaluated a single dose of four different ACWY-TT conjugate vaccine formulations in 240 toddlers (12–14 months) and 268 children (3–5 years) compared to licensed age-appropriate control vaccines. In toddlers, rSBA-MenC GMTs for the selected formulation were statistically higher than after monovalent-MenC-conjugate vaccine. In children, rSBA-GMTs against each serogroup were statistically higher than after tetravalent polysaccharide vaccine. The safety profile was comparable to licensed controls. The new ACWY-TT conjugate vaccine promises high seroprotection levels against meningococcal disease from 1 year of age.