TetanusNCT07107932
A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
An observational study of Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tetanus
- What is being tested?
- Siltartoxatug Injection (Brand name: Sintetol®)
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 4 sitesChina
- Study dates
- 31 Jul 2025to 30 Mar 2029
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.
Who may be able to join
- 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
- 2. Provided signed informed consent by themselves or their legal representatives.
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong, 515041
Tianliang Huang, Doctor, +86 13531168261, 276578698@qq.com
- Recruiting
Shaoxing Central Hospital
Shaoxing, Zhejiang, 312030
Liyun Wang, +86 0575-85580999
- Not yet recruiting
Xiangyun County People's Hospital
Xiangyun, Yunnan, 672100
Yuanzuo Zhang, +86 13769215316, 511846092@qq.com
- Not yet recruiting
Zhoushan Putuo District People's Hospital
Zhoushan, Zhejiang, 316100
Li Hu, +86 0580-3030785
About this study
Official title: A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.
- Conditions
- Tetanus
- Being tested
- Siltartoxatug Injection (Brand name: Sintetol®)
- Keywords
- Tetanus Prophylaxis
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siltartoxatug Injection (Brand name: Sintetol®)Drug
The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.
| Study group | Role | What they receive |
|---|---|---|
| Siltartoxatug Injection (Brand name: Sintetol®) | Not described Receives: Drug: Siltartoxatug Injection (Brand name: Sintetol®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)
Measured: within 90 days
Secondary outcomes (2)
Secondary Outcome
Classification of wound characteristics in patients receiving Siltartoxatug Injection
Measured: within 90 days
Secondary Outcome
Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start31 Jul 2025
- Primary completion30 Mar 2029 (estimated)
- Study completion30 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 90 Days
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
- NCT07107932
- Sponsor's protocol ID
- TNM002-402
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
- ClinicalTrials.gov ID
- NCT07107932
- Acronym / sponsor ID
- TNM002-402
- Conditions
- Tetanus
- Keywords
- Tetanus Prophylaxis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Siltartoxatug Injection (Brand name: Sintetol®) | – | Drug: Siltartoxatug Injection (Brand name: Sintetol®) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.
Key inclusion criteria (2 listed)
- 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
- 2. Provided signed informed consent by themselves or their legal representatives.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siltartoxatug Injection (Brand name: Sintetol®)The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration. | Drug | Siltartoxatug Injection (Brand name: Sintetol®) |
Primary outcome
Primary Outcome
Time frame: within 90 days
Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)
2 secondary outcomes
Secondary Outcome
Time frame: within 90 days
Secondary Outcome
Time frame: within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Qu, Master (+86 0756 726399, sammi.qu@trinomab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.