Clinical trial Recruiting at 1 site Observational Ages 18 and up

Siltartoxatug for tetanus protection after injury

Official 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

Run by Zhuhai Trinomab Pharmaceutical Co., Ltd. · NCT07347938 · Data updated 2026-11-12

This study tests whether siltartoxatug can protect adults after injury from tetanus and compares it with other passive immunizing options.

More Tetanus trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment6000 (estimated)
SponsorZhuhai Trinomab Pharmaceutical Co., Ltd.
Industry-sponsored
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJanuary 14, 2026
Main results expectedDecember 31, 2028
Study endsMarch 31, 2029
Registry record updatedJuly 27, 2026
Trial IDNCT07347938 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (18+) with injuries requiring passive tetanus prophylaxis and who are treated with siltartoxatug or another passive immunizing agent per labeling.

Probably not a fit

Patients not receiving tetanus prophylaxis, those with very short life expectancy, or those with cognitive or other conditions preventing tetanus assessment may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls about 6,000 adults with injuries requiring tetanus prophylaxis across hospitals in China. Participants choosing siltartoxatug are assigned to the treatment group, while those receiving HTIG, TAT, or F(ab')₂ form the control group. Investigators manage standard wound care and tetanus vaccination per routine practice, documenting outcomes to assess safety and effectiveness. The study is led by Zhuhai Trinomab and is conducted at The Second Affiliated Hospital Zhejiang University School of Medicine. No randomization or interventional procedures beyond routine clinical care are required.

Why it matters

Potential benefit: If successful, siltartoxatug could provide an effective alternative for tetanus protection after injury.

How similar studies have gone: Previous observational experiences with tetanus passive immunizers provide context, but direct evidence for siltartoxatug in this setting is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.