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The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNA02-48 | Experimental | If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48 |
|
| Human tetanus immunoglobulin (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 |
|---|---|---|---|---|
| SNA02-48 | Drug | IM gluteal injection |
| |
| Human tetanus immunoglobulin (HTIG) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 study drug |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of tetanus | Up to 105 days after receipt of study drug | |
| anti-tetanus neutralizing antibody titers | Up to 90 days after receipt of study drug | |
| Incidence of adverse events |
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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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe County People's Hospital | Fuyang | Anhui | 236699 | China | ||
| The Second Affiliated Hospital of Anhui Medical University |
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| Drug |
IM gluteal injection |
|
| Up to 105 days after receipt of study drug |
| Incidence of severe adverse events (SAEs) | Up to 105 days after receipt of study drug |
| To evaluate the plasma concentration of SNA02-48 | Up to 90 days after receipt of study drug |
| Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab) | Up to 90 days after receipt of study drug |
| Hefei |
| Anhui |
| 230601 |
| China |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510150 | China |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University | Guangzhou | Guangdong | 510440 | China |
| The Fifth Affiliated Hospital of Southern Medical University | Guangzhou | Guangdong | 510900 | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518025 | China |
| Longhua District People's Hospital of Shenzhen | Shenzhen | Guangdong | 518100 | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | 545000 | China |
| Liuzhou People's Hospital | Liuzhou | Guangxi | 545200 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Wuhan Union Hospital | Wuhan | Hubei | 430022 | China |
| Affiliated Nanhua Hospital, University of South China | Hengyang | Hunan | 421010 | China |
| Taizhou People's Hospital | Taizhou | Jiangsu | 225300 | China |
| Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu | 225000 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212013 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330008 | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | 337000 | China |
| Weifang People's Hospital | Weifang | Shandong | 261000 | China |
| Linfen Central Hospital | Linfen | Shanxi | 041000 | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | 030032 | China |
| Yuncheng Central Hospital, Shanxi Province | Yuncheng | Shanxi | 044099 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Lishui Central Hospital | Lishui | Zhejiang | 323020 | China |
| Ningbo Medical Center Li Huili Hospital | Ningbo | Zhejiang | 315000 | China |
| 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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