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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| The University of Hong Kong-Shenzhen Hospital |
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This observational study is an open-label, prospective, multi-center design. The goal is to evaluate the long-term clinical survival outcomes at 3 months and 1 year in individuals under 18 years of age with WHO Category III rabies exposure who have received real-world Post-Exposure Prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection / other passive immunization products combined with the rabies vaccine.
Participants will: (1) Have their clinical protection outcomes (rabies-free survival status) registered and evaluated on Day 90 and Day 365. (2) Have the option to provide a blood sample on Day 7 for Rabies Virus Neutralizing Antibody (RVNA) testing. (3) Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYN023 combined with rabies vaccine | |||
| Other rabies passive immunization products combined with rabies vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Rabies-free survival rate | WHO's Classification of Rabies Cases: Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result. | 3 months and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions and adverse events | 42 days | |
| Incidence of serious adverse reactions and serious adverse events | 126 days | |
| Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals under 18 years of age with category III rabies exposure who have received post-exposure prophylaxis (PEP) with Zamerovimab and Mazorelvimab Injection /other passive immunization products combined rabies vaccine in the real world
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangjun Li | Contact | +86 0512-8765807 | xjli@synermore.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| OTHER |
| University of South China Affiliated Nanhua Hospital | UNKNOWN |
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| Day 7 |
| Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL | Day 7 |
| Shenzhen second people's hospital | Recruiting | Shenzhen | Guangdong | China |
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| The University of Hong Kong - Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | China |
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| Affiliated Nanhua Hospital, University of South China | Recruiting | Hengyang | Hunan | China |
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| Jiangxi Provincial Chest Hospital | Recruiting | Nanchang | Jiangxi | China |
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| D007239 | Infections |