NCT07107932

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jul 2025Mar 2029

First Submitted

Initial submission to the registry

July 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

January 6, 2026

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

July 28, 2025

Last Update Submit

January 4, 2026

Conditions

Keywords

Tetanus Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

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

    within 90 days

Secondary Outcomes (2)

  • Secondary Outcome

    within 90 days

  • Secondary Outcome

    within 90 days

Study Arms (1)

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.

Siltartoxatug Injection (Brand name: Sintetol®)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Zhoushan Putuo District People's Hospital

Zhoushan, Zhejiang, 316100, China

NOT YET RECRUITING

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 6, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 30, 2029

Last Updated

January 6, 2026

Record last verified: 2025-07

Locations