Close
Close

Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen

Access Programs

Disease Information

Descriptive Information
Brief Title † Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
Official Title † Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults
Brief Summary The aim of the study is to document the safety and immunogenicity of Purified Vero Rabies Vaccine (VRVg) when given in a simulated post-exposure regimen, i.e. with co-administration of human rabies immunoglobulins (Imovax® Rabies). Primary Objectives: - To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 14. - To demonstrate that the observed proportion of subjects achieving an RVNA titer ≥ 0.5 IU/mL at Day 14 is at least 99%, with a lower limit of the 95% confidence interval (CI) of at least 97%. Secondary Objectives: - To assess the clinical safety of each vaccine after each vaccine injection when administered in a simulated post-exposure schedule. - To describe the geometric mean titer ratio (GMTR) between the 2 vaccine groups at Day 14.
Detailed Description All participants will receive five vaccine injections, i.e. one at Day 0, at Day 3, at Day 7, at Day 14 and at Day 28, respectively, (Essen regimen). In addition, human rabies immunoglobulins (HRIG) will be concomitantly administered to all subjects on Day 0. 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 6 months post-vaccination 5.
Study Phase Phase 2
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary Outcome Measure † Number of participants with rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42 (14 days after the last vaccination of primary vaccination series).
Secondary Outcome Measure † Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Condition † Rabies
Intervention † BiologicalPurified Vero Rabies Vaccine (VRVg)
Study Arms / Comparison Groups Purified Vero Rabies Vaccine Group Participants will receive the Purified Vero Rabies Vaccine (VRVg) Imovax® Rabies Vaccine Group Participants will receive the Imovax® Rabies vaccine
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 342
Start Date † June 2013
Completion Date September 2014
Primary Completion Date May 2014
Eligibility Criteria † Inclusion Criteria: - Aged 18 to
Gender Both
Ages 18 Years - 64 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01877395
Organization ID VRV04
Secondary IDs †† U1111-1117-7447
Responsible Party Sponsor
Study Sponsor † Sanofi Pasteur, a Sanofi Company
Collaborators ††
Investigators † Study Director: Medical Director, Sanofi Pasteur SA
Information Provided By
Verification Date November 2014
First Received Date † June 10, 2013
Last Updated Date November 17, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
Find a Clinical Trial
Related Videos
by Abidemi Uruejoma
187 views
Free Newsletter