title: Safety and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine after one or two doses given to infants and toddlers.
abstract: With the emergence of multiple meningococcal serogroups in different geographic areas, broad vaccine protection from infancy is desirable. One hundred and seventy-five infants received either two doses of a meningococcal quadrivalent (A, C, W-135, Y) conjugate vaccine (MenACWY-CRM) at 6 and 12 months, one dose of MenACWY-CRM at 12 months, or MenC at 12 months and MenACWY-CRM at 18 months. Bactericidal antibody titers using human complement were measured before and 1 month after each dose. Injection-site reactions were reported by 22-45% of participants following MenACWY-CRM given at 6 or 12 months. Similar proportions of subjects had injection-site reactions following two doses of MenACWY-CRM (32-41%) or one dose of MenC (26-44%). The incidence of systemic adverse events was comparable between groups. After two doses of MenACWY-CRM, the percentages of participants reporting hSBA titers >or=8 were 100% for C, W-135, and Y, and 84% for A. Serogroup C titers were more than 10-fold higher after two doses of MenACWY-CRM than after one dose of MenC or MenACWY-CRM at 12 months. Serogroup C titers were comparable following a single dose of MenACWY-CRM or MenC at 12 months. MenACWY-CRM is well tolerated and immunogenic given at 12 months, or two doses at 6 and 12 months of age.
authors.affiliation: Clinical Trials Research Center, Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, 5850/5980 University Avenue, Halifax, NS, B3K 6R8, Canada. scott.halperin@dal.ca
authors.forename: S A
authors.initials: SA
authors.lastname: Halperin
authors.forename: F
authors.initials: F
authors.lastname: Diaz-Mitoma
authors.forename: P
authors.initials: P
authors.lastname: Dull
authors.forename: A
authors.initials: A
authors.lastname: Anemona
authors.forename: F
authors.initials: F
authors.lastname: Ceddia
mesh_terms: D000704:Analysis of Variance; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000276:immunology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology*; D015610:Serum Bactericidal Test; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate