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Study sites were selected from hospitals across diverse regions of China. Approximately 6,000 participants who require passive immunization against tetanus due to various injuries (including those with severe wounds or heavily contaminated injuries) will be enrolled. Per clinical practice:
Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000); Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siltartoxatug Injection | Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000). |
| |
| HTIG, TAT, or F(ab')₂ | Participants receiving other passive immunizing agents (HTIG, TAT, or F(ab')₂) for tetanus prophylaxis and meeting eligibility criteria will be assigned to the control group (n=2,000), comprising approximately 1,000 HTIG recipients and 1,000 TAT/F(ab')₂ recipients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltartoxatug Injection | Drug | Dosage form: Injectable solution Strength: 10 mg / 0.5 mL per vial Route and regimen: Single intramuscular injection in the gluteal muscle at a dose of 10 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing | within 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective | Tetanus protection rate (1 - tetanus incidence rate) within 28 days post-dosing | within 28 days |
| Secondary Objective | Incidence rates of adverse events (AEs) and serious adverse events (SAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults (≥18 years of age) who require passive immunization against tetanus following injury.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Qu, Master | Contact | +86 0756 726399 | sammi.qu@trinomab.com | |
| xinyu Liu, Doctor | Contact | +86 0756 7263999 | liuxinyu@trinomab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | 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 |
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| HTIG/TAT/F(ab')₂ | Drug | Dosage form, strength, and administration: As specified in the respective product's approved labeling (package insert). All use will follow routine clinical practice per local guidelines. |
|
| within 90 days |
| D007239 | Infections |