A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

NCT07347938 | Not Yet Recruiting FDA Drug

• 1 other identifier: TNM002-401
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tetanus

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing

  within 90 days

Secondary Outcomes (2)

• Secondary Objective

  within 28 days

• Secondary Objective

  within 90 days

Study Arms (2)

Siltartoxatug Injection

Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000).

Drug: Siltartoxatug Injection

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

Drug: HTIG/TAT/F(ab')₂

Interventions

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

Siltartoxatug Injection

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.

HTIG, TAT, or F(ab')₂

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years of age) who require passive immunization against tetanus following injury.

You may qualify if:

• Male or female aged ≥18 years.
• Receiving siltartoxatug for tetanus prophylaxis per its approved labeling, or receiving another passive immunizing agent (human tetanus immunoglobulin \[HTIG\], tetanus antitoxin \[TAT\], or equine F(ab')₂ fragment \[F(ab')₂\]) for tetanus prophylaxis per its labeling.
• Receiving or planned to receive standard wound management.
• Providing written informed consent by the subject or their legally authorized representative.

You may not qualify if:

• Life expectancy \<3 months.
• Severe cognitive impairment or other condition interfering with the assessment of tetanus development.
• Currently participating in another interventional clinical trial (observational studies are permitted).

Sponsors & Collaborators

• Zhuhai Trinomab Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Xia Qu, Master

CONTACT

+86 0756 726399; sammi.qu@trinomab.com

xinyu Liu, Doctor

CONTACT

+86 0756 7263999; liuxinyu@trinomab.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 16, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

CN (1)