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ADACEL®: Tetanus

A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

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

Fase: Fase 4
Estado: Completado
Participantes: 1.564
Centros: 19
Fin del objetivo primario: sep 2008

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2007.

Qué mide

Geometric Mean Titers (GMTs) of Tetanus, Diphtheria, and Pertussis Antibodies Pre- and Post-Vaccination With ADACEL® or DECAVAC® Vaccine (Day 35 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIt is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.

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Ficha completa en ClinicalTrials.gov (NCT00457249), actualizada en sep 2012.