NCT01784874

Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use

Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in Pre-exposure Use in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 408 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to generate data on immunogenicity and safety of Purified Vero Rabies Vaccine - Serum Free (VRVg) in comparison with Imovax® Rabies in order to support the registration of VRVg in the USA. Primary Objectives: * To demonstrate that VRVg is non inferior to Imovax® Rabies in terms of proportion of subjects achieving an rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42. * To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 42 is at least 99%, with a 95% lower confidence limit of at least 97%. Secondary Objectives: * To assess the clinical safety of VRVg each vaccine after each vaccine injection when administered in a pre-exposure schedule. * To describe the immune response induced by each vaccine 21 days after two vaccinations (Day 28) in a randomized subset of subjects and 14 days after the last vaccination of the primary vaccination series. * To describe antibody persistence at 6 and 12 months after the first vaccination in all subjects, and at 18 and 24 months in a subset of subjects.

Detailed description

The vaccination will be given in three injections, at Day 0, Day 7, and Day 28, respectively, based on the Advisory Committee on Immunization Practice (ACIP) and the World Health Organization (WHO) recommendations for pre-exposure regimen. A booster dose will be administered 1 year after the first vaccine injection in a randomized subset of participants. Safety will be assessed in all participants up to 28 days after vaccination, as applicable, in terms of occurrence of adverse events (AEs), and serious adverse events (SAEs) and adverse events of special interest (AESIs) up to Month 12.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Vero Rabies Vaccine (VRVg) - Serum Free	0.5 mL, Intramuscular
BIOLOGICAL	Imovax® Rabies: inactivated rabies vaccine	1.0 mL, Intramuscular

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-04-01
• Completion: 2015-12-01
• First posted: 2013-02-06
• Last updated: 2018-02-09

Locations

6 sites across 1 country: United States