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Purified inactivated rabies…

Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine

Ensayo de Sanofi en Rabies · Rabies Virus (del registro, en inglés).

Fase

Fase 3

Estado

Completado

Participantes

816

previstos

Centros

1

Fin del objetivo primario

mar 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en abr 2011.

Qué mide

Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination (del registro, en inglés) (dia 14)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Primary Objective: * To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over. Secondary Objectives: * To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall * To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01339312), actualizada en may 2014.