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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-4382 |
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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:
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRVg Group | Experimental |
| |
| Verorab Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified Vero Rabies Vaccine - Serum Free | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. | 42 days post-primary series vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety after Purified Vero Rabies Vaccine. | 0 to 7 days post-vaccination and entire study duration |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gières | 38610 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23510665 | Result | Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013 Apr 26;31(18):2295-301. doi: 10.1016/j.vaccine.2013.02.058. Epub 2013 Mar 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Purified inactivated rabies vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| Montpellier |
| 34094 |
| France |
| Pierre-Bénite | 69130 | France |
| Poitiers | 86000 | France |
| Rennes | 35000 | France |
| Rueil-Malmaison | 92502 | France |
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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