Last updated on August 2019

Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines in a Simulated Post-Exposure Regimen in Adults


Brief description of study

Primary Objective:

To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) is non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer 0.5 IU/mL at D28, ie, 14 days after the fourth vaccine injection.

Secondary Objective:

  • To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
  • To demonstrate that the proportion of subjects in the VRVg-2 + HRIG group achieving an RVNA titer 0.5 IU/mL at D28 is at least 95%.
  • To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at D14 (7 days after the third injection), at D28 (14 days after the fourth injection) and at D42 (14 days after the last injection).

Detailed Study Description

Study duration per participant will be approximately 7 months including: 1 day of screening and vaccination, a 28-day vaccination period, 1 safety-follow up visit at Day 42, 1 safety follow-up/end of study visit at Day 56 and a 6-month safety follow-up call after last vaccine administration.

Clinical Study Identifier: NCT03965962

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