Comparison of Purified Vero Rabies Vaccine, Serum Free With Human Diploid Cell Vaccine in Pre-exposure Use
Public ClinicalTrials.gov record NCT01784874. 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 of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in Pre-exposure Use in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01784874
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 408 participants
Conditions and interventions
Conditions
Interventions
- Purified Vero Rabies Vaccine (VRVg) - Serum Free 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
- Jan 31, 2013
- Primary completion
- Mar 31, 2014
- Completion
- Nov 30, 2015
- Last update posted
- Feb 8, 2018
2013 – 2015
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Redding | California | 96001 | — |
| Not listed | Sacramento | California | 95815 | — |
| Not listed | Omaha | Nebraska | 68134 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Fort Worth | Texas | 76135 | — |
| Not listed | Salt Lake City | Utah | 84124 | — |
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 NCT01784874, 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 Feb 8, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01784874 live on ClinicalTrials.gov.