MedTrace Logo

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

NCT03965962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2025-09-18

Study results available
· View outcomes & findings →

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).

Conditions

  • Rabies (Healthy Volunteers)

Interventions

BIOLOGICAL

VRVg-2

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

BIOLOGICAL

Purified Inactivated Rabies Vaccine

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

BIOLOGICAL

Human Diploid Cell Vaccine (HDCV)

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

BIOLOGICAL

Rabies immune globulin (human)

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-12-22
Completion
2021-07-01
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965962 on ClinicalTrials.gov