TetanusNCT07347938
A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
An observational study of Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- Siltartoxatug Injection and HTIG/TAT/F(ab')₂
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2026to 31 Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years of age) who require passive immunization against tetanus following injury.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Mao Zhang, Doctor, +86 13757119125, zmhz@hotmail.com
About this study
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
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
- Being tested
- Siltartoxatug Injection, HTIG/TAT/F(ab')₂
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siltartoxatug InjectionDrug
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')₂Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Siltartoxatug Injection | Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000). Receives: 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 Receives: Drug: HTIG/TAT/F(ab')₂ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
Measured: within 90 days
Secondary outcomes (2)
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 28 days and 130 days post-dosing
Measured: within 28 days and 130 days
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Measured: within 130 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start14 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347938
- Sponsor's protocol ID
- TNM002-401
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided