NCT01877395

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

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7, at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0. Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 6 months post-vaccination 5.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Vero Rabies Vaccine (VRVg)	0.5 mL, Intramuscular
BIOLOGICAL	Imovax® Rabies: inactivated rabies vaccine	1.0 mL, Intramuscular

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2013-06-13
• Last updated: 2014-12-03

Locations

5 sites across 1 country: United States