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NCT Number: NCT07347938

A 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Mao Zhang, Doctor

CONTACT

[email protected]

+86 13757119125

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

  1. Tetanus protection rate

    Time frame: within 90 days

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

Secondary outcomes

  1. Tetanus protection rate

    Time frame: within 28 days and 130 days

    Tetanus protection rate (1 - tetanus incidence rate) within 28 days and 130 days post-dosing

  2. Incidence rates of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: within 130 days

    Incidence rates of adverse events (AEs) and serious adverse events (SAEs)

Study contacts

Contact information is provided by the study sponsor or research team.

Xia Qu, Master

CONTACT

[email protected]

+86 0756 726399

Xinyu Liu, Doctor

CONTACT

[email protected]

+86 0756 7263999

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 16, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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