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NCT01877395 · ClinicalTrials.gov registry record · Phase 2
Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 342
- Enrollment target
NCT01877395 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 342 participants.
The verdict
NCT01877395, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 342 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Purified Vero Rabies Vaccine (VRVg)
- BIOLOGICAL Imovax® Rabies: inactivated rabies vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01877395
The ClinicalTrials.gov registry entry for NCT01877395 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 342 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Purified Vero Rabies Vaccine (VRVg) is the first listed.
NCT01877395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01877395 about?
NCT01877395 is a clinical study titled "Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen". 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 ...
What is the current status of trial NCT01877395?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2013-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01877395?
The interventions under investigation include: Purified Vero Rabies Vaccine (VRVg) (BIOLOGICAL), Imovax® Rabies: inactivated rabies vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01877395?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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