Actively Recruiting
A Multicentre, Randomized, Double-blind, Human Tetanus Immunoglobulin Controlled Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of GR2001 Injection for Tetanus Prevention
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2024-10-10
582
Participants Needed
20
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the safety and effectiveness of a new injection called GR2001 with Human Tetanus Immunoglobulin (HTIG) for preventing tetanus. This Phase III clinical trial focuses on adults who may have been exposed to tetanus through dirty or contaminated wounds. The study aims to see how well GR2001 works in raising protective antibody levels against tetanus. Participants will be randomly assigned to receive a single intramuscular injection of either GR2001 or HTIG in the gluteal muscle on the first day of the study. GR2001 is provided in a 5mg/1ml vial with specific packaging materials, while HTIG is a licensed human plasma-derived immunoglobulin. Both treatments are given once, and the study is designed as a double-blind trial. During the trial, researchers will monitor the increase in anti-tetanus antibody levels up to 12 hours after injection and follow participants for up to 105 days to observe the occurrence of tetanus and assess safety. They will also evaluate how GR2001 behaves in the body, including its peak concentration and overall exposure. Participants will undergo assessments and safety monitoring throughout this period to gather comprehensive data on the treatment effects.
CONDITIONS
Brief 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
- Prior vaccination with 3 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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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 hours
Participants receive a single intramuscular gluteal injection of either GR2001 or Human Tetanus Immunoglobulin (HTIG).
1 treatment visit (in-person)
Duration - Up to 105 days after treatment
Participants are monitored for safety, immunogenicity, and incidence of tetanus after treatment.
Visits over 105 days for monitoring and assessments
Trial Site Locations
Total: 20 locations
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
Research Team
C
Chuanlin Wang, MD
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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