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NCT01784874 · ClinicalTrials.gov registry record · Phase 2
Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
NCT01784874: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01784874 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 408 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01784874, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
Study 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.
Primary Outcome
Rabies virus neutralizing antibody titer will be determined by the rapid fluorescent focus inhibition test (RFFIT)
Interventions
- BIOLOGICAL Imovax® Rabies: inactivated rabies vaccine
- BIOLOGICAL Purified Vero Rabies Vaccine (VRVg) - Serum Free
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01784874 record still lists
NCT01784874 is an interventional study that assigns participants to a tested intervention. The registered 408 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 (207% higher).
The record links to 0 conditions, and to 2 interventions - of which Imovax® Rabies: inactivated rabies vaccine is the first listed.
NCT01784874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01784874 about?
NCT01784874 is a clinical study titled "Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use". 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 ...
What is the current status of trial NCT01784874?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2013-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01784874?
The interventions under investigation include: Imovax® Rabies: inactivated rabies vaccine (BIOLOGICAL), Purified Vero Rabies Vaccine (VRVg) - Serum Free (BIOLOGICAL).
Who is sponsoring clinical trial NCT01784874?
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 NCT01784874's enrollment target sits among peer trials
408 93rd of 2000 higher than 1,908 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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