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NCT07633119
A Phase Ⅲ Clinical Study of SNA02-48 Injection
Conditions: Tetanus
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 600
Sponsor: Sinovac Life Sciences Co., Ltd.
Location: Taihe County People's Hospital Fuyang Anhui
Summary
The primary objective of this clinical trial is to compare the efficacy and safety of SNA02-48 injection with Human Tetanus Immunoglobulin (HTIG) for tetanus prophylaxis.
Eligibility Criteria
Inclusion Criteria:
1. Males or females aged 18 years and above;
2. Participants who can understand and voluntarily sign the informed consent form;
3. Participants with high-risk tetanus exposure;
4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the time the participant signs the informed consent form until 6 months after administration, with no plans for sperm or egg donation.
Exclusion Criteria:
1. Suspected or confirmed tetanus ;
2. A history of previous tetanus infection;
3. A known history of 3 or more doses of tetanus toxoid or vaccines containing tetanus toxoid, or fewer than 3 previous doses but with the last dose of tetanus toxoid or vaccines containing tetanus toxoid administered within 6 months prior to the administration of the investigational product;
4. Known hypersensitivity to the investigational product (including excipients, HTIG, and other therapeutic monoclonal antibodies), or suffering from severe allergic diseases that, in the investigator's judgment, may impair the participant's safety; Other protocol defined Inclusion/Exclusion criteria may apply.
Source: ClinicalTrials.gov (NCT07633119). StuddyBuddy aggregates publicly available trial information.