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Recruiting NCT05664750

Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus

Conditions: Tetanus

Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 675
Sponsor: Trinomab Biotech Co., Ltd.

Location: China

Summary

TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.

Eligibility Criteria

Inclusion Criteria:Chinese male or female adults aged ≥ 18 years;Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;Participants who provide signed written informed consent form.Exclusion Criteria:Known or suspected allergy to the investigational product or its excipients, or have a history of allergy to human immunoglobulin products or other therapeutic monoclonal immunoglobulins;Suspect or diagnosed as tetanus;Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;Any clinically significant chronic or acute medical condition that makes the subject unsuitable for participation;Current alcohol abuse, drug abuse or drug addictionOther 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 (NCT05664750). StuddyBuddy aggregates publicly available trial information.