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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: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01877395 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 342 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
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 |
What the finished NCT01877395 record still lists
NCT01877395 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which Purified Vero Rabies Vaccine (VRVg) is the first listed.
NCT01877395 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01877395's enrollment target sits among peer trials
342 136th of 2000 higher than 1,864 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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