At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
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
Timeline
Interventions
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Pharmaceutical form: Powder and solvent for suspension for injection; Route of administration: IM
Pharmaceutical form: Solution for injection; Route of administration: IM