trauma
Conditions
Interventions
Equine anti-Tetanus F(ab’)2:N/A
Sponsors
Shanghai Jing'an District Zhongxin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: IN01: Patients aged between 18 years old (including 18 years old) and 65 years old (including 65 years old) who require tetanus immunoglobulin injection due to trauma, traffic accidents, and other injuries; IN02: The process of obtaining informed consent complies with GCP regulations.
Exclusion criteria
Exclusion criteria: EX01: Previously diagnosed with tetanus infection; EX02: Patients who received Tetanus vaccine injection within one month before the signature of informed consent; EX03: Patients who have been injected with the same type of product from horse origin (TAT, MABO) within the three months prior to the signing of the informed consent form; EX04: Patients with known allergies to horse tetanus immunoglobulin (F (ab ') 2); EX05: Previous or known cases of positive tetanus immunoglobulin (F (ab ') 2)/tetanus antitoxin skin test allergy test; EX06: those who need to be vaccinated with rabies vaccine or Antivenom at the same time; EX07: Patients who come to the hospital for treatment due to burns; EX08: patients with liver and kidney diseases, immune diseases and cardiovascular diseases (including coronary heart disease, Cerebrovascular disease, peripheral artery Vascular disease, Congenital heart defect, rheumatic heart disease, Deep vein thrombosis and Pulmonary embolism); EX09: Pregnant women or women planning to conceive during this study, lactating women; EX10: The researcher has determined that there is a disease that may interfere with the trial operation and results; EX11: Researchers believe that the subjects have poor compliance due to mental illness, psychological illness, or social factors; EX12: Subjects participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dst positive rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and level of adverse events (AEs) at 2 hours, 7 ± 1 days, and 14 ± 1 days after administration;The geometric mean titer of tetanus antibody IgG detected by ELISA on the third day and the proportion of subjects with a titer greater than 0.1 IU/mL; | — |
Countries
China
Contacts
Public ContactYinxiaoxing
Jing'an District Central Hospita,Shanghai
Outcome results
None listed