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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 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 408 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01784874
The ClinicalTrials.gov registry entry for NCT01784874 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 408 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 Imovax® Rabies: inactivated rabies vaccine is the first listed.
NCT01784874 reports 0 study locations.
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.
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