CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 640 enrolled
Drug / intervention
VRVg-2 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03965962
NCT03965962Phase 3Completed

Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France

Sanofi Pasteur, a Sanofi Company·interventional·Posted May 29, 2019·Updated Sep 18, 2025

In Brief

A Phase 3 clinical trial evaluating VRVg-2, Purified Inactivated Rabies Vaccine, and 2 other interventions for Rabies (Healthy Volunteers). Completed, enrolled 640 participants across 2 sites.

Detailed Summary

Primary Objective: To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (\>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 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 participants in the VRVg-2 + HRIG group achieving an RVNA titer \>= 0.5 IU/mL at Day 28 was at least 95 percent (%). * 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 Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 29, 2019
Enrollment StartJul 1, 2019
Primary CompletionDec 22, 2020
Study CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago

Interventions

VRVg-2biological

Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM

Purified Inactivated Rabies Vaccinebiological

Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM

Human Diploid Cell Vaccine (HDCV)biological

Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM

Rabies immune globulin (human)biological

Pharmaceutical form: Solution for injection; Route of administration: IM