Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
NCT ID: NCT05664750
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
675 participants
INTERVENTIONAL
2022-12-22
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TNM002
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
TNM002
Dosage Form: Injection, solution
Route of administration: IM gluteal injection
Human tetanus immunoglobulin (HTIG)
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Human tetanus immunoglobulin (HTIG)
Dosage Form: Injection, solution
Route of administration: IM gluteal injection
Interventions
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TNM002
Dosage Form: Injection, solution
Route of administration: IM gluteal injection
Human tetanus immunoglobulin (HTIG)
Dosage Form: Injection, solution
Route of administration: IM gluteal injection
Eligibility Criteria
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Inclusion Criteria
2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;
3. Participants who provide signed written informed consent form.
Exclusion Criteria
2. Suspect or diagnosed as tetanus;
3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;
5. Current alcohol abuse, drug abuse or drug addiction
18 Years
ALL
No
Sponsors
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Zhuhai Trinomab Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chuanlin Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Shengyi Wang
Role: STUDY_DIRECTOR
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Locations
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Hefei First People's Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China
Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
Zhejiang Provincial People's Hospital
Hangzhou, Hangzhou, China
The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Affiliated Nanhua Hospital, University of South China
Hengyang, Hunan, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
PKUCare Luzhong Hospital
Zibo, Shandong, China
The First People's Hospital of Jinzhong
Jinzhong, Shanxi, China
Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
Taiyuan, Shanxi, China
Yuncheng Central Hospital - East Campus
Yuncheng, Shanxi, China
Countries
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References
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Wang CL, Liu S, Shao ZJ, Yin ZD, Chen QJ, Ma X, Ma C, Wang Q, Wang LH, Deng JK, Li YX, Zhao ZX, Wu D, Wu J, Zhang L, Yao KH, Gao Y, Xie X. [Guidelines for the use of post-traumatic tetanus vaccines and passive immune preparation]. Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Dec 6;53(12):1212-1217. doi: 10.3760/cma.j.issn.0253-9624.2019.12.005. Chinese.
Roper MH, Vandelaer JH, Gasse FL. Maternal and neonatal tetanus. Lancet. 2007 Dec 8;370(9603):1947-59. doi: 10.1016/S0140-6736(07)61261-6.
Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.
Yu Chao, Xu Yuming, Xu Jin, et al. Progress of clinical application and safety of tetanus antitoxin. Chinese Journal of Pharmacovigilance, 2016, 13 (1): 36-41.
Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41.
Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691.
Ortiz JR, Hombach J. Announcing the publication of the WHO immunological basis for immunization series module on influenza vaccines. Vaccine. 2018 Sep 5;36(37):5504-5505. doi: 10.1016/j.vaccine.2017.09.010. Epub 2017 Oct 16.
Forrat R, Dumas R, Seiberling M, Merz M, Lutsch C, Lang J. Evaluation of the safety and pharmacokinetic profile of a new, pasteurized, human tetanus immunoglobulin administered as sham, postexposure prophylaxis of tetanus. Antimicrob Agents Chemother. 1998 Feb;42(2):298-305. doi: 10.1128/AAC.42.2.298.
Liang Z, Liu S, Guo W, Deng Z, Bin W, Yu A, Hu J, Wu L, Li Z, Huang W, Li H, Cheng D, Li S, Guo Q, Zhang D, Yan X, Wang C, Cai W, Ding B, Li W, Li X, Xu B, He L, Ouyang Y, Zhan H, Wang J, Zhao Y, Liu X, Xiang W, Zhang M, Zhang Z, Ding J, Kuang X, Zheng W, Liao H, Wang W, Wang C. Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial. Nat Med. 2025 Aug;31(8):2673-2681. doi: 10.1038/s41591-025-03791-8. Epub 2025 Jul 8.
Related Links
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Srivastava P, B.K.C.J., Trends in tetanus epidemiology in the United States, 1972-2001. 39th National Immunization Conference Workshop 27, 2005. Available at: \<http://cdc.confex.com/cdc/nic2005/techprogram/paper\_7813.htm\>. 2005.
Other Identifiers
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TNM002-301
Identifier Type: -
Identifier Source: org_study_id
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