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Tetanus Toxoid

Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

Ensayo de Sanofi en Tetanus · Diphtheria · Pertussis · Whooping Cough (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

423

previstos

Centros

8

Fin del objetivo primario

mar 2013

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2012.

Qué mide

Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine (Day 0 (pre-vaccination) to Day 28 (post-vaccination)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to \<13 years of age. Primary objective: * To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. Observational objectives: * To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine. * To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.

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Ficha completa en ClinicalTrials.gov (NCT01629589), actualizada en feb 2016.