NCT00948272

Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults

Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration. Primary Objective: * To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series. Secondary Objectives: * To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects. * To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.

Detailed description

All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Vero Rabies Vaccine - Serum Free	0.5 mL, Intramuscular
BIOLOGICAL	Purified inactivated rabies vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-02-01
• Completion: 2011-08-01
• First posted: 2009-07-29
• Last updated: 2014-05-28

Locations

6 sites across 1 country: France