Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen

Summary

The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies). 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 Day 14. * To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%. Secondary Objectives: * To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule. * To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.

Timeline

Start

2013-06

Primary completion

2014-05

Completion

2014-09

Drugs

Indications