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

A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tetanus
• Intervention / Treatment: Drug: Siltartoxatug Injection; Drug: HTIG/TAT/F(ab')₂

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Xia Qu, Master; Phone Number: +86 0756 726399; Email: sammi.qu@trinomab.com
• Study Contact Backup: Name: xinyu Liu, Doctor; Phone Number: +86 0756 7263999; Email: liuxinyu@trinomab.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Mao Zhang, Doctor; Phone Number: +86 13757119125; Email: zmhz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing	within 90 days

Secondary Outcome Measures

Outcome Measure	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)	within 90 days

Collaborators and Investigators

• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Tetanus
• Other Study ID Numbers: TNM002-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No