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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-7193 | Other Identifier | WHO |
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This study is designed to gather safety and immunogenicity data with Purified Vero Rabies Vaccine - Serum Free (VRVg), when given in a post-exposure prophylaxis vaccination schedule, using the Essen regimen, across different populations.
Primary Objective:
Secondary Objectives:
All participants will receive five vaccinations (on Days 0, 3, 7, 14, and 28) and will be assessed for immunogenic response on Days 0, 14, and 42. They will also be monitored for safety from the day of the first vaccination and for up to 6 months after the final vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRVg Vaccine Group 1 | Experimental | Participants aged 18 years or older will receive Purified Vero Rabies Vaccine Serum Free (VRVg) |
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| VRVg Vaccine Group 2 | Experimental | Participants aged 10 to 17 years will receive Purified Vero Rabies Vaccine Serum Free (VRVg) |
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| Verorab Vaccine Group 1 | Active Comparator | Participants aged 18 years or older will receive Verorab Vaccine |
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| Verorab Vaccine Group 2 | Active Comparator | Participants aged 10 to 17 years will receive Verorab Vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purified inactivated rabies vaccine, serum free | Biological | 0.5 mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Information on the rabies virus neutralizing antibody (RVNA) titer post vaccination | Rabies virus neutralizing antibody (RVNA) titer as determined by rapid fluorescent focus inhibition test (RFFIT) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination. | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. | Day 1 up to 6 months post last vaccination |
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Inclusion Criteria:
Adults (≥ 18 years)
Subjects aged 10-17 years:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanning | Guangxi | 530028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24148575 | Result | Li R, Huang L, Li J, Mo Z, He B, Wang Y, Wu X, Minutello M, Guinet-Morlot F, Pichon S. A next-generation, serum-free, highly purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab(R) when administered according to a post-exposure regimen in healthy children and adults in China. Vaccine. 2013 Dec 5;31(50):5940-7. doi: 10.1016/j.vaccine.2013.10.043. Epub 2013 Oct 19. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Purified inactivated rabies vaccine, serum free | Biological | 0.5 mL, Intramuscular |
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| Purified Vero Rabies Vaccine | Biological | 0.5 mL, Intramuscular |
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| Purified Vero Rabies Vaccine | Biological | 0.5 mL, Intramuscular |
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| 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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