ClinicalTrials.gg
RecruitingNCT07107932Updated Jan 6, 2026

A Registry: Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

An observational study in Tetanus, sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd.. Recruiting at 4 sites in China. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Zhuhai Trinomab Pharmaceutical Co., Ltd. · Observational

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10,000
Sex
All
01

Study 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. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.

02

Conditions studied

  • Tetanus

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Keywords

  • Tetanus Prophylaxis
03

In context

Tetanus

318 studies on the registry are indexed under Tetanus; 29 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 645 across 35 observational studies indexed under Tetanus.

Browse Tetanus studies →

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
  • 2. Provided signed by themselves or their legal representatives.

Exclusion criteria

Exclusion Criteria:

  • None
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Siltartoxatug Injection (Brand name: Sintetol®)

    Drug: Siltartoxatug Injection (Brand name: Sintetol®)

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. Primary Outcome

    Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)

    Time frame: within 90 days

Secondary outcomes

  1. Secondary Outcome

    Classification of wound characteristics in patients receiving Siltartoxatug Injection

    Time frame: within 90 days

  2. Secondary Outcome

    Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection

    Time frame: within 90 days

07

Study locations

1 of 4 sites recruiting
  • The Second Affiliated Hospital of Shantou University
    Shantou, Guangdong 515041, China
    Not yet recruiting
  • Xiangyun County People's Hospital
    Xiangyun, Yunnan 672100, China
    Not yet recruiting
  • Shaoxing Central Hospital
    Shaoxing, Zhejiang 312030, China
    Recruiting
    • Liyun Wang · Contact+86 0575-85580999
  • Zhoushan Putuo District People's Hospital
    Zhoushan, Zhejiang 316100, China
    Not yet recruiting
    • Li Hu · Contact+86 0580-3030785
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07107932
Lead sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Jul 31, 2025
Primary completion
Mar 30, 2029 (estimated)
Completion
Mar 30, 2029 (estimated)
Last update
Jan 6, 2026

Study contacts

Xia Qu, Master
Contact
sammi.qu@trinomab.com
+86 0756 726399
xinyu Liu, Doctor
Contact
liuxinyu@trinomab.com
+86 0756 7263999

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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