A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

Trinomab

Status: Not yet enrolling

Conditions: Tetanus

Treatments: Drug: HTIG/TAT/F(ab')₂; Drug: Siltartoxatug Injection

Study type: Observational

Funder types: Industry

Identifiers

NCT07347938

TNM002-401

Details and patient eligibility

About

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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

6,000 participants in 2 patient groups

Siltartoxatug Injection

Description:

Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000).

Treatment:

Drug: Siltartoxatug Injection

HTIG, TAT, or F(ab')₂

Description:

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

Treatment:

Drug: HTIG/TAT/F(ab')₂