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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

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Abstract

  • ▲ 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.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania, 19067, USA

    James E. Frampton & Susan J. Keam

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  1. James E. Frampton
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  2. Susan J. Keam
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Correspondence to James E. Frampton.

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Frampton, J.E., Keam, S.J. Reduced-Antigen, Combined Diphtheria-Tetanus-Acellular Pertussis Vaccine, Adsorbed (Boostrix® US Formulation). Pediatr-Drugs 8, 189–195 (2006). https://doi.org/10.2165/00148581-200608030-00005

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