Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT05664750
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 675}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2024-03-06', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-22', 'dispFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to 105 days after receipt of study drug'}, {'measure': 'Incidence of treatment related adverse events (AEs)', 'timeFrame': 'Up to 105 days after receipt of study drug'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'Up to 105 days after receipt of study drug'}, {'measure': 'The number and percentage of subjects with abnormal hematology tests', 'timeFrame': 'Up to 90 days after receipt of study drug', 'description': 'The hemotology tests include red blood cell count, hemoglobin, platelet count, white blood cell count, absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocytes percentage, absolute monocyte count, and hematocrit'}, {'measure': 'The number and percentage of subjects with abnormal serum chemistry tests', 'timeFrame': 'Up to 90 days after receipt of study drug', 'description': 'The serum chemistry tests include total protein, albumin, sodium, potassium, chloride, calcium, glucose, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct bilirubin, urea (blood urea nitrogen) and creatinine'}, {'measure': 'The number and percentage of subjects with abnormal urinalysis tests', 'timeFrame': 'Up to 90 days after receipt of study drug', 'description': 'The urinalysis tests include protein, glucose, urobilinogen, urine occult blood, red blood cell and white blood cell'}, {'measure': 'The number and percentage of subjects with abnormal vital signs', 'timeFrame': 'Up to 90 days after receipt of study drug', 'description': 'The vital signs include blood pressure, pulse rate, respiratory rate, and body temperature'}, {'measure': 'The number and percentage of subjects with abnormal physical examination', 'timeFrame': 'Up to 90 days after receipt of study drug', 'description': 'The physical examination includes skin, lymph nodes, eyes, head and neck, chest, abdomen, spine, extremities.'}, {'measure': 'The number and percentage of subjects with abnormal 12-lead electrocardiogram (ECG)', 'timeFrame': 'Up to 90 days after receipt of study drug'}], 'primaryOutcomes': [{'measure': 'Proportion of participants with an increase of anti-tetanus neutralizing antibody titers (∆ titers) over protective level.', 'timeFrame': 'Baseline up to 12 hours after receipt of study drug'}], 'secondaryOutcomes': [{'measure': 'Tetanus protection rate (1 - tetanus incidence)', 'timeFrame': 'Up to 28 days after receipt of study drug'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tetanus', 'Prophylaxis'], 'conditions': ['Tetanus']}, 'referencesModule': {'references': [{'pmid': '31795577', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17854885', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28185446', 'type': 'BACKGROUND', 'citation': 'Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '5902706', 'type': 'BACKGROUND', 'citation': 'Perey BJ. Progress in tetanus prophylaxis: the advent of human antitoxin. Can Med Assoc J. 1966 Feb 26;94(9):437-41.'}, {'type': 'BACKGROUND', 'citation': "Plotkin, S.A., W.A. Orenstein and P.A. Offit, Plotkin's vaccines. Seventh edition. ed. 2018. 1691."}, {'pmid': '29042200', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9527776', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40628965', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://cdc.confex.com/cdc/nic2005/techprogram/paper_7813.htm', 'label': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese male or female adults aged ≥ 18 years;\n2. Participants with dirty or contaminated wounds caused by various injury who require passive immunization as prophylaxis against tetanus;\n3. Participants who provide signed written informed consent form.\n\nExclusion Criteria:\n\n1. 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;\n2. Suspect or diagnosed as tetanus;\n3. Previously diagnosed as Immunoglobulin A (IgA) deficiency with anti-IgA antibodies\n4. Prior vaccination history of ≥ 3 doses of tetanus toxoid or tetanus toxoid- containing vaccine;\n5. Current alcohol abuse, drug abuse or drug addiction\n\nOther protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05664750', 'briefTitle': 'Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhuhai Trinomab Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Phase III Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus', 'orgStudyIdInfo': {'id': 'TNM002-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNM002', 'description': 'If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002', 'interventionNames': ['Drug: TNM002']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Human tetanus immunoglobulin (HTIG)', 'description': 'If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG', 'interventionNames': ['Drug: Human tetanus immunoglobulin (HTIG)']}], 'interventions': [{'name': 'TNM002', 'type': 'DRUG', 'description': 'Dosage Form: Injection, solution\n\nRoute of administration: IM gluteal injection', 'armGroupLabels': ['TNM002']}, {'name': 'Human tetanus immunoglobulin (HTIG)', 'type': 'DRUG', 'description': 'Dosage Form: Injection, solution\n\nRoute of administration: IM gluteal injection', 'armGroupLabels': ['Human tetanus immunoglobulin (HTIG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230061', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': "Hefei First People's Hospital", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230601', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510062', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510150', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '511407', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518025', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen Second People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '545007', 'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': "Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University", 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'zip': '563000', 'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'Affiliated Hospital of Zunyi Medical College', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'zip': '570311', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '310014', 'city': 'Hangzhou', 'state': 'Hangzhou', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '430014', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430062', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '421010', 'city': 'Hengyang', 'state': 'Hunan', 'country': 'China', 'facility': 'Affiliated Nanhua Hospital, University of South China', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}, {'zip': '330008', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '750003', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '255499', 'city': 'Zibo', 'state': 'Shandong', 'country': 'China', 'facility': 'PKUCare Luzhong Hospital', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}, {'zip': '030602', 'city': 'Jinzhong', 'state': 'Shanxi', 'country': 'China', 'facility': "The First People's Hospital of Jinzhong", 'geoPoint': {'lat': 37.68403, 'lon': 112.75471}}, {'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '044099', 'city': 'Yuncheng', 'state': 'Shanxi', 'country': 'China', 'facility': 'Yuncheng Central Hospital - East Campus', 'geoPoint': {'lat': 35.02306, 'lon': 110.99278}}], 'overallOfficials': [{'name': 'Chuanlin Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Shengyi Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhuhai Trinomab Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuhai Trinomab Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}