NCT03145766

Immunogenicity and Safety of a Purified Vero Rabies Vaccine

Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free When Administered According to a Simulated Rabies Post-exposure Regimen in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Detailed description

This study assessed different formulations of the modified formulation of VRVg (VRVg 2- formulations 1 \[low\], 2 \[medium\] and 3 \[high\]) tested in parallel to the initial VRVg formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events were also reported.

Conditions

• Rabies Virus

Interventions

Type	Name	Description
BIOLOGICAL	VRVg 2	Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free
BIOLOGICAL	VRVg 1	Initial formulation of Purified Vero Rabies Vaccine Serum Free
BIOLOGICAL	Imovax Rabies	Purified inactivated rabies vaccine prepared on human diploid cell cultures
BIOLOGICAL	VRVg 2	Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free
BIOLOGICAL	VRVg 2	Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free
BIOLOGICAL	Human Rabies Immunoglobulins (HRIG)	Commercialized formulation of HRIG

Timeline

• Start date: 2017-04-17
• Primary completion: 2018-01-08
• Completion: 2018-01-08
• First posted: 2017-05-09
• Last updated: 2022-04-19
• Results posted: 2021-01-28

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study