Clinical trials

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.

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.