NCT07633119Not yet recruitingPhase 3
A Multicenter, Randomized, Double-Blind, Active-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of SNA02-48 Injection in Populations With High-Risk Tetanus Exposure
Sinovac Life Sciences Co., Ltd.30 sites in 1 country600 target enrollmentStarted: June 28, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 600
- Locations
- 30
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females aged 18 years and above;
- •Participants who can understand and voluntarily sign the informed consent form;
- •Participants with high-risk tetanus exposure;
- •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
- •Suspected or confirmed tetanus ;
- •A history of previous tetanus infection;
- •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;
- •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.
Investigators
Study Sites (30)
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