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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Zhuhai Trinomab Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2029 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07347938 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
- Study coordinator: Xia Qu, Master
- Email: sammi.qu@trinomab.com
- Phone: +86 0756 726399
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Two-Component Diphtheria-Tetanus-Pertussis Vaccine in Adults and Adolescents
This trial tests different doses of an absorbed acellular pertussis-containing DTP vaccine in people aged 10 and older to see how well it works and how safe it is.
-
Diphtheria, Tetanus, Pertussis, and Poliovirus Vaccine Trial in Young Children
This is a small early-phase study testing a diphtheria, tetanus, pertussis and polio vaccine formulation in children from 2 months to 6 years to see if it is safe and can provoke an immune response.
-
Community spread of multiple infectious diseases in Cambodia from a One Health perspective
This project will test how common and connected dengue, chikungunya, Zika, Japanese encephalitis, and West Nile infections are among people, animals, and the environment across Cambodia.
-
Siltartoxatug injection to prevent tetanus after injury
This registry will follow people who receive Siltartoxatug after an injury to see if it prevents tetanus and to record any side effects.
-
Web-based program to improve pregnant mothers' understanding of and intent to get influenza and Tdap vaccines.
This trial will test whether a short web-based education program helps pregnant women understand and feel more likely to get influenza and Tdap vaccines.
-
Tdap and RSV vaccines in pregnancy: same visit versus separate visits
This project will see if giving the RSV and Tdap vaccines together at one prenatal visit or at separate visits is safe and protects pregnant people and their babies better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.