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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00948272 |
Purpose
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Rabies |
Biological: Purified Vero Rabies Vaccine - Serum Free Biological: Purified inactivated rabies vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults |
| Estimated Enrollment: | 384 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| VRVg Group: Experimental |
Biological: Purified Vero Rabies Vaccine - Serum Free
0.5 mL, Intramuscular
|
| Verorab Group: Active Comparator |
Biological: Purified inactivated rabies vaccine
0.5 mL, Intramuscular
|
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations| France | |
| Gières, France, 38610 | |
| Pierre Bénite, France, 69130 | |
| Rennes, France, 35000 | |
| Montpellier Cedex 5, France, 34094 | |
| Poitiers, France, 86000 | |
| Rueil Malmaison, France, 92502 | |
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
| Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
| Study ID Numbers: | VRV01, UTN: U1111-1111-4382 |
| Study First Received: | July 28, 2009 |
| Last Updated: | January 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00948272 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Rabies Rabies virus Purified Vero Rabies Vaccine Serum Free |
|
Virus Diseases RNA Virus Infections Rabies Rhabdoviridae Infections Mononegavirales Infections |