Actively Recruiting
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2024-10-10
582
Participants Needed
20
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase III Clinical Trail to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity Characteristics of GR2001 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese male or female adults aged 18 years or older
- Participants with suspected tetanus exposure due to dirty or contaminated wounds
- Participants who provide signed written informed consent
You will not qualify if you...
- Known allergy to the investigational product or severe allergic conditions
- Suspected or diagnosed tetanus infection
- Diagnosed Immunoglobulin A (IgA) deficiency with anti-IgA antibodies
- History of three or more doses of tetanus toxoid or tetanus-containing vaccine
- Females who are pregnant or have a positive pregnancy test
AI-Screening
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Trial Site Locations
Total: 20 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
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2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
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3
Peking University People Hospital
Beijing, Beijing Municipality, China, 100044
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4
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
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5
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
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6
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150
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7
Zhujiang Hospital Affiliated to Southern Medical University
Guangzhou, Guangdong, China, 510280
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8
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518037
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9
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545006
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10
Liuzhou Workers's Hospital
Liuzhou, Guangxi, China, 545025
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11
The Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
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12
The Central Hospital of Wuhan
Wuhan, Hubei, China, 430014
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13
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
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14
Nanhua Hospital Affiliated to University of south China
Hengyang, Hunan, China, 421010
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15
The Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu, China, 225009
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16
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
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17
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
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18
Linfen Central Hospital
Linfen, Shanxi, China, 041000
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19
Yuncheng Central Hospital
Yuncheng, Shanxi, China, 044000
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20
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
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Research Team
C
Chuanlin Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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