Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07633119). StuddyBuddy aggregates publicly available trial information.