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The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR2001 | Experimental | If randomized to GR2001, participant will receive a single IM gluteal injection of GR2001 |
|
| HTIG | Active Comparator | If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2001 | Biological | The packaging for GR2001 injection uses a borosilicate glass vial, a brominated halobutyl rubber stopper for injectable solutions and an aluminum-plastic combination cap for antibiotic vials as its primary packaging materials. The specification is 5mg/1ml per vial. |
| Measure | Description | Time Frame |
|---|---|---|
| The increase of anti-tetanus neutralizing antibody titers (∆ titers) | The proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level. | Baseline up to 12 hours after receipt of Investigational medicinal product. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of tetanus | Up to 105 days after receipt of Investigational medicinal product. | |
| To evaluate the safety of GR2001 | Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanlin Wang, MD | Contact | 86+13911883012 | wangchuanlinvip@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanlin Wang, MD | Peking University People's Hospital | Principal Investigator |
| Zhanfei Li, MD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| HTIG | Biological | The HTIG is a Chinese licensed Human Tetanus Immunoglobulin produced by Tonglu-Bio, which are derived from human plasma, and then purified and filled in the injectable vial form. |
|
| Up to 105 days after receipt of Investigational medicinal product. |
| To evaluate the peak plasma concentration(Cmax) of GR2001 | Up to 105 days after receipt of Investigational medicinal product. |
| To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR2001 | Up to 105 days after receipt of Investigational medicinal product. |
| To evaluate the immunogenicity of GR2001 | Up to 105 days after receipt of Investigational medicinal product. |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Peking University People Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510150 | China |
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| Zhujiang Hospital Affiliated to Southern Medical University | Recruiting | Guangzhou | Guangdong | 510280 | China |
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| Shenzhen Second People's Hospital | Recruiting | Shenzhen | Guangdong | 518037 | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | Guangxi | 545006 | China |
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| Liuzhou Workers's Hospital | Recruiting | Liuzhou | Guangxi | 545025 | China |
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| The Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
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| The Central Hospital of Wuhan | Recruiting | Wuhan | Hubei | 430014 | China |
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| Tongji Hospital, Tongji Medical College of HUST | Recruiting | Wuhan | Hubei | 430030 | China |
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| Nanhua Hospital Affiliated to University of south China | Recruiting | Hengyang | Hunan | 421010 | China |
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| The Affiliated Hospital of Yangzhou University | Recruiting | Yangzhou | Jiangsu | 225009 | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| Linfen Central Hospital | Recruiting | Linfen | Shanxi | 041000 | China |
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| Yuncheng Central Hospital | Recruiting | Yuncheng | Shanxi | 044000 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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