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TetanusPhase 3NCT05664750

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

A Phase 3 study testing TNM002 and Human tetanus immunoglobulin (HTIG) in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tetanus
What is being tested?
TNM002 and Human tetanus immunoglobulin (HTIG)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
675 participants
Where
28 sitesChina
Study dates
22 Dec 2022to 7 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510062

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511407

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Zhejiang Provincial People's Hospital

    Hangzhou, Hangzhou, 310014

  • Hefei First People's Hospital

    Hefei, Anhui, 230061

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Affiliated Nanhua Hospital, University of South China

    Hengyang, Hunan, 421010

  • The First People's Hospital of Jinzhong

    Jinzhong, Shanxi, 030602

  • Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University

    Liuzhou, Guangxi, 545007

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518025

  • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)

    Taiyuan, Shanxi, 030032

  • The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology

    Wuhan, Hubei, 430014

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • Yuncheng Central Hospital - East Campus

    Yuncheng, Shanxi, 044099

  • PKUCare Luzhong Hospital

    Zibo, Shandong, 255499

  • Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: 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

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.

Conditions
Tetanus
Being tested
TNM002, Human tetanus immunoglobulin (HTIG)
Keywords
Tetanus, Prophylaxis
Medical subject headings
Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNM002Drug

    Dosage Form: Injection, solution

    Route of administration: IM gluteal injection

  • Human tetanus immunoglobulin (HTIG)Drug

    Dosage Form: Injection, solution

    Route of administration: IM gluteal injection

Study groups in NCT05664750
Study groupRoleWhat they receive
TNM002ExperimentalIf randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
Receives: Drug: TNM002
Human tetanus immunoglobulin (HTIG)Active comparatorIf randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Receives: Drug: Human tetanus immunoglobulin (HTIG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose

    The change of anti-tetanus neutralizing antibody titers from baseline were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters ≥0.01 IU/mL.

    Measured: Baseline up to 12 hours after receipt of study drug

Secondary outcomes (1)

  1. Tetanus Protection Rate on Day 28 Post-dose

    The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.

    Measured: Up to 28 days after receipt of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start22 Dec 2022
  3. Primary completion24 Mar 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized and receive a single intramuscular injection (IM) gluteal injection of TNM002 or human tetanus immunoglobulin (HTIG).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
675 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664750
Sponsor's protocol ID
TNM002-301
Status last verified
Oct 2023
First submitted
7 Dec 2022
Last updated
1 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Deidentified individual participant data are available under restricted access. Trinomab will assess all requests for additional data sharing. Requests should be sent to Trinomab with a detailed proposal outlining the intended use and the responses can be expected within one month. A signed data access agreement with Trinomab is required prior to data sharing.

Publications

  • 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.

    PubMed 31795577

  • 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.

    PubMed 17854885

  • Tetanus vaccines: WHO position paper - February 2017. Wkly Epidemiol Rec. 2017 Feb 10;92(6):53-76. No abstract available. English, French.

    PubMed 28185446

  • 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.

    PubMed 5902706

  • 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.

    PubMed 29042200

  • 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.

    PubMed 9527776

  • 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.

    PubMed 40628965

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TNM002 and Human tetanus immunoglobulin (HTIG) in people with Tetanus, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose (time frame: Baseline up to 12 hours after receipt of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664750, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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