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Purified Vero Rabies Vaccine…

Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen

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

Fase

Fase 2

Estado

Completado

Participantes

342

previstos

Centros

2

Fin del objetivo primario

ago 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, simple ciego. Comenzó en sep 2013.

Qué mide

Number Subjects with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL as measured by rapid fluorescent focus inhibition test (RFFIT) (del registro, en inglés) (dia 42)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years. Primary Objectives: * To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination. * To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group. Secondary Objectives: * To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule. * To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination * To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01930357), actualizada en abr 2017.