Calendario›SNY›Fluzone®: Influenza Virus…

Fluzone®: Influenza Virus…

Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine

Ensayo de Sanofi en Gripe.

Más ensayos de: Gripe.

Fase

Fase 4

Estado

Completado

Participantes

120

previstos

Centros

1

Fin del objetivo primario

feb 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2005.

Qué mide

Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Fluzone® Vaccination (Day 0 to 3 post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroTo describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00258830), actualizada en abr 2016.