title: Reduced-antigen, combined diphtheria-tetanus-acellular pertussis vaccine, adsorbed (Boostrix) US formulation): use as a single-dose booster immunization in adolescents aged 10-18 years.
abstract: black triangle Boostrix US formulation (hereafter referred to as Tdap) is a formulation of reduced-antigen, combined diphtheria-tetanus-acellular pertussis vaccine, adsorbed onto aluminium approved in the US for use as a single-dose booster immunization in adolescents aged 10-18 years. The diphtheria and tetanus toxoid components of Tdap elicited serologic immune responses comparable to those induced by an approved diphtheria-tetanus (Td) booster vaccine in a large (n = 4114), randomized, observer-blind, multicenter, pivotal trial in US adolescents aged 10-18 years. In addition, antibody levels against pertussis antigens (pertussis toxoid, filamentous hemagglutinin, and pertactin) induced by Tdap were non-inferior to, and numerically higher than, those induced in infants who completed a three-dose primary immunization course with combined diphtheria-tetanus-acellular pertussis vaccine (Infanrix), which conferred 89% protection against pertussis. Tdap had a similar reactogenicity profile, including solicited local reactions and general symptoms, to that of the approved Td vaccine in the pivotal US study. In particular, Tdap was similar (non-inferior) to Td with respect to the primary safety endpoint, namely the incidence of grade 3 pain at the injection site within the 15-day post-vaccination period. No serious adverse events of potential autoimmune origin or of a new-onset, chronic nature were reported during the 6-month post-vaccination period in the pivotal US study and a smaller (n = 319) German-based trial that also evaluated Tdap.
authors.affiliation: Adis International Inc., Yardley, PA 19067, USA. demail@adis.co.nz
authors.forename: James E
authors.initials: JE
authors.lastname: Frampton
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Keam
mesh_terms: D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000276:immunology* / Q000378:metabolism; D001886:Bordetella pertussis / Q000276:immunology*; D002648:Child; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D016032:Randomized Controlled Trials as Topic; D014917:Whooping Cough / Q000097:blood / Q000276:immunology / Q000517:prevention & control
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines