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2009-2010 Trivalent Influenza…
A Study of Influenza Virus Vaccines in Children and Adults
Ensayo de Sanofi en Gripe.
Más ensayos de: Gripe.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 600
- Centros
- 4
- Fin del objetivo primario
- dic 2009
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2009.
Qué mide
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. (Day 0 up to 7 days post-vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Primary Objective: To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults. Observational Objectives: * To describe the safety of the 2009-2010 TIV among subjects ≥6 months to \<5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age. * To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to \<5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00988143), actualizada en nov 2013.