Phase 4 Study to Assess Safety and Effectiveness of Siltartoxatug Injection Compared to Other Passive Immunizing Agents for Tetanus Prevention After Injury

What this Trial Is About

Researchers are evaluating the effectiveness and safety of siltartoxatug injection compared to other passive immunizing agents for tetanus prevention following injury. This multicenter, prospective, non-randomized, open-label phase 4 study includes approximately 6,000 participants from various hospitals in China who require passive immunization due to injuries such as severe wounds or heavily contaminated injuries. Participants will be assigned to either the siltartoxatug group, receiving a single intramuscular injection of 10 mg siltartoxatug, or the control group, receiving other passive immunizing agents like human tetanus immunoglobulin HTIG, tetanus antitoxin TAT, or equine Fab fragment according to their approved labeling and standard clinical practice. All participants will also receive or plan to receive standard wound management and tetanus vaccination as determined by investigators. During the study, participants will be monitored for tetanus protection rates within 90 days, with additional assessments at 28 and 130 days. Safety will be evaluated by tracking adverse events and serious adverse events within 130 days. The study involves observation and data collection on clinical management and outcomes, with participation lasting up to the study completion date in 2029.

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