Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
Tetanus
About this trial
This is an interventional treatment trial for Tetanus focused on measuring Tetanus, Prophylaxis
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; Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine; Current alcohol abuse, drug abuse or drug addiction Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Hefei First People's Hospital
- The Second Hospital of Anhui Medical University
- Peking University First Hospital
- Peking University People's Hospital
- Beijing Tiantan Hospital Affiliated to Capital Medical University
- The First Affiliated Hospital, Sun Yat-sen University
- Guangdong Provincial Hospital of Chinese Medicine
- The Third Affiliated Hospital of Guangzhou Medical University
- Guangzhou First People's Hospital
- Nanfang Hospital of Southern Medical University
- The First Affiliated Hospital of Guangzhou Medical University
- Shenzhen Second People's Hospital
- Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
- Affiliated Hospital of Zunyi Medical College
- Hainan General Hospital
- Zhejiang Provincial People's Hospital
- The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
- Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
- Renmin Hospital of Wuhan University
- Zhongnan Hospital of Wuhan University
- The Second Xiangya Hospital of Central South University
- Affiliated Nanhua Hospital, University of South China
- The Second Affiliated Hospital of Nanchang University
- General Hospital of Ningxia Medical University
- PKUCare Luzhong Hospital
- The First People's Hospital of Jinzhong
- Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
- Yuncheng Central Hospital - East Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
TNM002
Human tetanus immunoglobulin (HTIG)
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG