Study of Purified Vero Rabies Vaccine and Rabies Human Diploid Cell Vaccine in a Simulated Rabies Post-exposure Regimen
Public ClinicalTrials.gov record NCT01877395. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Rabies Human Diploid Cell Vaccine (Imovax® Rabies) Administered in a Simulated Rabies Post-exposure Regimen in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01877395
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 342 participants
Conditions and interventions
Conditions
Interventions
- Purified Vero Rabies Vaccine (VRVg) Biological
- Imovax® Rabies: inactivated rabies vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 64 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2013
- Primary completion
- Apr 30, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Dec 2, 2014
2013 – 2014
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Pembroke Pines | Florida | 33026 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Boise | Idaho | 59802 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01877395, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2014 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01877395 live on ClinicalTrials.gov.