Calendario›SNY›Influenza Virus Vaccine:…
Influenza Virus Vaccine:…
Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 200
- Centros
- 4
- Fin del objetivo primario
- nov 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en sep 2012.
Qué mide
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine (Day 0 up to Day 7 post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18 years to \<65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to \<65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age). Primary Objective: * To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the safety of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone, Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To submit remaining available sera from subjects given Fluzone vaccine to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01691339), actualizada en ago 2013.