[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619693":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":38,"responsibleParty":57,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":10,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Zhuhai Trinomab Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Siltartoxatug Injection",null,"Participants receiving siltartoxatug for tetanus prophylaxis and meeting eligibility criteria will be assigned to the siltartoxatug group (n=4,000).",[13],"Drug: Siltartoxatug Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"HTIG, TAT, or F(ab')₂","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\u002FF(ab')₂ recipients",[18],"Drug: HTIG\u002FTAT\u002FF(ab')₂",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Dosage form: Injectable solution Strength: 10 mg \u002F 0.5 mL per vial Route and regimen: Single intramuscular injection in the gluteal muscle at a dose of 10 mg",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"HTIG\u002FTAT\u002FF(ab')₂","Dosage 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.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Xia Qu, Master","CONTACT","+86 0756 726399","sammi.qu@trinomab.com",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"xinyu Liu, Doctor","+86 0756 7263999","liuxinyu@trinomab.com",[39],{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310009","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.16142,30.29365,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":10,"email":56},"Mao Zhang, Doctor","+86 13757119125","zmhz@hotmail.com",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100619693","a-phase-4-study-to-evaluate-the-effectiveness-and-safety-of-siltartoxatug-injection-for-tetanus-prophylaxis-following-injury-100619693",false,"NCT07347938","A Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","A Multicenter, Prospective, Non-Randomized, Open-Label, Active-Controlled Phase 4 Study to Evaluate the Effectiveness and Safety of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* 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.\n* Receiving or planned to receive standard wound management.\n* Providing written informed consent by the subject or their legally authorized representative.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C3 months.\n* Severe cognitive impairment or other condition interfering with the assessment of tetanus development.\n* Currently participating in another interventional clinical trial (observational studies are permitted).","ALL","18 Years",{"count":69,"type":70},6000,"ESTIMATED","OBSERVATIONAL","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:\n\nParticipants 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\u002FF(ab')₂ recipients. All clinical management decisions, including concomitant tetanus vaccination, will be made by investigators per standard clinical practice at each center.",[74],"Tetanus","NOT_YET_RECRUITING","2026-01-08",{"date":78,"type":79},"2026-01-16","ACTUAL",{"date":81,"type":70},"2026-01-05",{"date":83,"type":70},"2029-03-31",{"name":5,"class":6},1]