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Influenza Virus Vaccine No…

Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

Ensayo de Sanofi en Influenza · Orthomyxoviridae Infections (del registro, en inglés).

Más ensayos de: Gripe.

Fase

Fase 4

Estado

Completado

Participantes

32

previstos

Centros

1

Fin del objetivo primario

ene 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2008.

Qué mide

Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 (Day 0 to Day 3 post-vaccination 1) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to \< 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to \< 5 years of age.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00755274), actualizada en abr 2016.