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Fluzone®: Influenza Virus…

Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

Ensayo de Sanofi en Gripe.

Más ensayos de: Gripe.

Fase

Fase 4

Estado

Completado

Participantes

60

previstos

Centros

2

Fin del objetivo primario

dic 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2012.

Qué mide

Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) (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 clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine. Objective: * To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives: * To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to \< 9 years of age. * To submit remaining available sera from subjects 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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Ficha completa en ClinicalTrials.gov (NCT01691326), actualizada en mar 2014.