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.
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.
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).
Adults (≥18 years of age) who require passive immunization against tetanus following injury.
Cohort
Prospective
Siltartoxatug Injection
DrugDosage 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')₂
DrugDosage 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.
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing
Tetanus protection rate
Tetanus protection rate (1 - tetanus incidence rate) within 28 days and 130 days post-dosing
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Incidence rates of adverse events (AEs) and serious adverse events (SAEs)
Click on the lead sponsor to view all of their trials.
