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COMPLETED
NCT05664750
PHASE3

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

Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

675

Start Date

2022-12-22

Completion Date

2023-07-07

Last Updated

2026-09-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

TNM002

Dosage Form: Injection, solution Route of administration: IM gluteal injection

DRUG

Human tetanus immunoglobulin (HTIG)

Dosage Form: Injection, solution Route of administration: IM gluteal injection

Locations (28)

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