A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection

Recruiting now · Phase 3

Conditions studied: Tetanus

In brief

The goal of this clinical trial is to compare the efficacy and safety of GR2001 injection with Human Tetanus Immunoglobulin(HTIG) in tetanus prophylaxis. Patients will receive either GR2001 injection or HTIG on study D0.

Key facts

Study ID

NCT06635798

Run by

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

People needed

582

Starts

2024-09-03

Expected to finish

2025-03-04

Last updated by the study team

2024-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chinese male or female adults aged ≥ 18 years；
• Participants with suspected tetanus exposure (due to dirty or contaminated wounds from various injuries);
• Participants who provide signed written informed consent form.

You may not qualify if…

• Participants known to be allergic to the investigational medicinal product or those suffering from severe allergic conditions；
• 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;
• Females who are pregnant or with pregnancy test positive.

Where it is running

• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University People Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (enrolling)
• Zhujiang Hospital Affiliated to Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (enrolling)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (enrolling)
• Liuzhou Workers's Hospital — Liuzhou, Guangxi, China (enrolling)
• The Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
• The Central Hospital of Wuhan — Wuhan, Hubei, China (enrolling)
• Tongji Hospital, Tongji Medical College of HUST — Wuhan, Hubei, China (enrolling)
• Nanhua Hospital Affiliated to University of south China — Hengyang, Hunan, China (enrolling)
• The Affiliated Hospital of Yangzhou University — Yangzhou, Jiangsu, China (enrolling)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Linfen Central Hospital — Linfen, Shanxi, China (enrolling)
• Yuncheng Central Hospital — Yuncheng, Shanxi, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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