title: Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents--A single blind randomized trial.
abstract: Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.
authors.affiliation: a Universidad Nacional Autónoma de México; , México City , Mexico.
authors.forename: Noris
authors.initials: N
authors.lastname: Pavia-Ruz
authors.forename: Katia
authors.initials: K
authors.lastname: Abarca
authors.forename: Alejandro
authors.initials: A
authors.lastname: Lepetic
authors.forename: Maria Yolanda
authors.initials: MY
authors.lastname: Cervantes-Apolinar
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
authors.forename: Girish
authors.initials: G
authors.lastname: Jayadeva
authors.forename: Sherine
authors.initials: S
authors.lastname: Kuriyakose
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
authors.forename: Manuel
authors.initials: M
authors.lastname: de la O
mesh_terms: D000293:Adolescent; D000906:Antibodies / Q000032:analysis; D000941:Antigens / Q000032:analysis; D002648:Child; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D016037:Single-Blind Method; D013594:Syringes; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: D000906:Antibodies; D000941:Antigens; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines
keywords: ANCOVA, analysis of co-variance; ATP, according to protocol; CI, confidence interval; El.U, Elisa units; FHA, filamentous hemagglutinin; GI, gastrointestinal; GMC, geometric mean concentration; IU, international units; LL, lower limit; PRN, pertactin; PT, pertussis toxin; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; booster; dTpa, reduced-antigen-content diphtheria tetanus and acellular pertussis vaccine; diphtheria; pertussis; syringe presentation; tetanus