title: A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years.
abstract: Incidence of meningococcal diseases is high in children, and effective vaccines are needed for this age group. In this phase II, open, controlled study, 309 children aged 2-10 y from Finland were randomized (3:1) into two parallel groups to receive one dose of meningococcal ACWY-tetanus toxoid conjugate vaccine (ACWY-TT group; n = 231) or a licensed meningococcal ACWY polysaccharide vaccine (Men-PS group; n = 78). Serum bactericidal activity using rabbit complement (rSBA) was evaluated up to three years post-vaccination. Exploratory comparisons suggested that rSBA vaccine response rates and geometric mean titers (GMTs) for each serogroup at one month post-vaccination and rSBA GMTs for serogroups A, W-135 and Y up to three years post-vaccination were higher in the ACWY-TT compared with Men-PS group, but did not detect any difference between groups in terms of rSBA-MenC GMTs at three years post-vaccination; this is explained by the higher proportion of children from the Men-PS group who were excluded because they were re-vaccinated with a monovalent meningococcal serogroup C vaccine due to loss of protective antibody levels against this serogroup. Although there was a higher incidence of local reactogenicity in the ACWY-TT group, general and unsolicited symptoms reporting rates were comparable in both groups. This study showed that MenACWY-TT was immunogenic with a clinically acceptable safety profile in children aged 2-10 y. MenACWY-TT induced higher functional antibody titers for all serogroups, which persisted longer for serogroups A, W-135 and Y, than the MenACWY polysaccharide vaccine.
authors.affiliation: Vaccine Research Center; University of Tampere, Tampere, Finland. timo.vesikari@uta.fi
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Aino
authors.initials: A
authors.lastname: Forstén
authors.forename: Dominique
authors.initials: D
authors.lastname: Boutriau
authors.forename: Véronique
authors.initials: V
authors.lastname: Bianco
authors.forename: Marie
authors.initials: M
authors.lastname: Van der Wielen
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D003165:Complement System Proteins / Q000276:immunology; D005260:Female; D005387:Finland; D006801:Humans; D008297:Male; D008585:Meningitis, Meningococcal / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D013997:Time Factors
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; C576777:tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine; D003165:Complement System Proteins