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Trivalent inactivated influenza…
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 9.172
- Centros
- 98
- Fin del objetivo primario
- may 2011
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2009.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol».
Qué mide
Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. (Day 0 (pre-vaccination) up to Year 1 post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly. Primary objective: To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations. Secondary objectives: * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus. * To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00976027), actualizada en jul 2012.