NCT01339312

Study of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Post-exposure Use in Healthy Subjects in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 816 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

Summary

This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations. Primary Objective: * To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab vaccine, in terms of proportion of participants with a rabies virus neutralizing antibody titer ≥ 0.5 IU/mL at Day 14, i.e., before the fourth vaccination, in participants aged 10 to 17 years and in participants aged 18 years and over. Secondary Objectives: * To assess the clinical safety of VRVg after each vaccination when administered in a post-exposure prophylaxis vaccination schedule in each respective age group and overall * To describe the immune response induced by VRVg before the fourth vaccination and 14 days after the last vaccination in each respective age groups and overall.

Detailed description

All participants will receive five vaccinations (on Days 0, 3, 7, 14, and 28) and will be assessed for immunogenic response on Days 0, 14, and 42. They will also be monitored for safety from the day of the first vaccination and for up to 6 months after the final vaccination.

Conditions

• Rabies
• Rabies Virus

Interventions

Type	Name	Description
BIOLOGICAL	Purified inactivated rabies vaccine, serum free	0.5 mL, Intramuscular
BIOLOGICAL	Purified inactivated rabies vaccine, serum free	0.5 mL, Intramuscular
BIOLOGICAL	Purified Vero Rabies Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	Purified Vero Rabies Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-03-01
• Completion: 2012-09-01
• First posted: 2011-04-20
• Last updated: 2014-05-28

Locations

1 site across 1 country: China