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

August 9, 2026 updated by: Zhuhai Trinomab Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

675

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230061
        • Hefei First People's Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100070
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangzhou, Guangdong, China, 510062
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510150
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 511407
        • The First Affiliated Hospital of Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518025
        • Shenzhen Second People's Hospital
    • Guangxi
      • Liuzhou, Guangxi, China, 545007
        • Liuzhou Worker's Hospital - Fourth Affiliated Hospital of Guangxi Medical University
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical College
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310014
        • Zhejiang Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430062
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430014
        • The Central Hospital of Wuhan, Tongji Medical College Huazhong University of Science&Technology
    • Hunan
      • Changsha, Hunan, China, 410011
        • The second Xiangya Hospital of Central South University
      • Hengyang, Hunan, China, 421010
        • Affiliated Nanhua Hospital, University of South China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330008
        • The Second Affiliated Hospital of Nanchang University
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • General hospital of ningxia medical university
    • Shandong
      • Zibo, Shandong, China, 255499
        • PKUCare Luzhong Hospital
    • Shanxi
      • Jinzhong, Shanxi, China, 030602
        • The First People's Hospital of Jinzhong
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Academy of Medical Sciences - Shanxi Bethune Hospital (Shanxi Dayi Hospital)
      • Yuncheng, Shanxi, China, 044099
        • Yuncheng Central Hospital - East Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Chinese male or female adults aged ≥ 18 years;
  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:

  1. 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;
  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

Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TNM002
If randomized to TNM002, participant will receive a single IM gluteal injection of TNM002
Drug: TNM002

Dosage Form: Injection, solution

Route of administration: IM gluteal injection
Active Comparator: Human tetanus immunoglobulin (HTIG)
If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG
Drug: Human tetanus immunoglobulin (HTIG)

Dosage Form: Injection, solution

Route of administration: IM gluteal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline up to 12 hours after receipt of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tetanus Protection Rate on Day 28 Post-dose
Time Frame: Up to 28 days after receipt of study drug
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.
Up to 28 days after receipt of study drug

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With ΔTiters ≥0.01 IU/mL on Days 3, 7, 28, and 90 Post-dose.
Time Frame: Up to 90 days after receipt of study drug
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.
Up to 90 days after receipt of study drug
∆Titers at 12 Hours, and on Days 3, 7, 28 and 90 Post-dose
Time Frame: At 12 hours, and on Days 3, 7, 28 and 90 post-dose
The change of anti-tetanus neutralizing antibody titers 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.
At 12 hours, and on Days 3, 7, 28 and 90 post-dose
Tetanus Protection Rate on Days 90 and 105 Post-dose
Time Frame: Up to 105 days after receipt of study drug
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.
Up to 105 days after receipt of study drug
TNM002 Serum Concentration
Time Frame: pre-dose, 12h, and Days 3, 7, 28, 90 post-dose
Arithmetic mean concentrations of TNM002 at each specified timepoint
pre-dose, 12h, and Days 3, 7, 28, 90 post-dose
Anti-drug Antibodies (ADA) Against TNM002
Time Frame: pre-dose, and Days 7, 28, and 90 post-dose
The positive rate of ADA in the TNM002 group at each specified timepoint
pre-dose, and Days 7, 28, and 90 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Chuanlin Wang, MD, Peking University People's Hospital
  • Study Director: Shengyi Wang, Zhuhai Trinomab Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Actual)

March 24, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 9, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNM002-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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