Calendario›SNY›Diphtheria
Diphtheria
Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older
Ensayo de Sanofi en Diphtheria · Tetanus · Poliomyelitis · Pertussis (del registro, en inglés).
Más ensayos de: Poliomielitis.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 342
- Centros
- 12
- Fin del objetivo primario
- may 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2011.
Qué mide
Diphtheria seroprotection rate (28 to 35 days afeter each vaccine administration) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objective: * To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years * To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects Secondary objectives: * If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years * To describe the immune responses to REPEVAX in these subjects * To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01287949), actualizada en sep 2017.