A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

Not yet recruiting

• Conditions: Tetanus

• Registration Number: NCT07107932
• Lead Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

Brief Summary

The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-28
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
• 2. Provided signed informed consent by themselves or their legal representatives.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	within 90 days	Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	within 90 days	Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection

Trial Locations

Locations (4)

The Second Affiliated Hospital of Shantou University; 🇨🇳 Shantou, Guangdong, China

Xiangyun County People's Hospital; 🇨🇳 Xiangyun, Yunnan, China

Shaoxing Central Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Zhoushan Putuo District People's Hospital; 🇨🇳 Zhoushan, Zhejiang, China