Tetanus
Conditions
Brief summary
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.
Interventions
DRUGSiltartoxatug Injection
Dosage 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
DRUGHTIG/TAT/F(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.
Sponsors
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tetanus protection rate | within 90 days | Tetanus protection rate (1 - tetanus incidence rate) within 90 days post-dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tetanus protection rate | within 28 days and 130 days | 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) | within 130 days | Incidence rates of adverse events (AEs) and serious adverse events (SAEs) |
Countries
China
Contacts
CONTACTXia Qu, Master
CONTACTXinyu Liu, Doctor
Outcome results
None listed