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PVRV

Immunogenicity and Safety of Verorab® in a "One-week" Intradermal Post-exposure Prophylaxis Regimen

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

Fase

Fase 3

Estado

Completado

Participantes

600

previstos

Centros

1

Fin del objetivo primario

nov 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2012.

Qué mide

Percentage of participants with seroconversion on Day 14 (Day 14 post vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to assess the 4-site "one-week" post-exposure prophylaxis (PEP) regimen as a possible alternative to the 2-site updated Thai Red Cross (TRC) PEP regimen. Primary objective: * To demonstrate that PEP using the new "one-week, 4-site" (4-4-4-0-0) intradermal (ID) vaccination regimen is non-inferior to PEP using the updated TRC (2-2-2-0-2) ID vaccination regimen. Secondary objectives: * Primary immunization: To describe the immune response in each group at Day 0, Day 14 and Day 90. * Antibody persistence: To describe rabies virus-neutralizing antibody persistence during the 5 years after completion of PEP in each group. * Booster vaccination: To describe the immune response induced by a single-visit 4-site intradermal booster vaccination in each group at Year 5. * Safety: To describe the safety profile of each group after the primary and booster vaccinations.

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Ficha completa en ClinicalTrials.gov (NCT01622062), actualizada en abr 2022.