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Adacel®: Tetanus Toxoid
Study of Adacel® Vaccine Administered to Persons 10 Years of Age
Ensayo de Sanofi en Tetanus · Diphtheria · Pertussis (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 1.302
- Centros
- 34
- Fin del objetivo primario
- nov 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2011.
Qué mide
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine (Day 30 post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. Secondary Objective: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01311557), actualizada en abr 2016.