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

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Disease Information

Descriptive Information
Brief Title † Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
Official Title † 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
Brief 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 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.
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) - Serum Free
Study Arms / Comparison Groups Purified Vero Rabies Vaccine Group Participants will receive the Purified Vero Rabies Vaccine (VRVg) Serum Free Imovax® Rabies Vaccine Group Participants will receive the Imovax® Rabies
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 † 410
Start Date † February 2013
Completion Date August 2015
Primary Completion Date November 2013
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 † NCT01784874
Organization ID VRV02
Secondary IDs †† U1111-1124-7459
Responsible Party Sponsor
Study Sponsor † Sanofi Pasteur, a Sanofi Company
Collaborators ††
Investigators † Study Director: Medical Director, Sanofi Pasteur SA
Information Provided By
Verification Date December 2014
First Received Date † February 4, 2013
Last Updated Date December 5, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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