A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
NCT ID: NCT06083623
Last Updated: 2023-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
2250 participants
INTERVENTIONAL
2023-10-06
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TNM001
TNM001
single dose intramuscular injection
Placebo
placebo
single dose intramuscular injection
Interventions
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TNM001
single dose intramuscular injection
placebo
single dose intramuscular injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 2\. History of RSV infection or active RSV infection prior to, or at the time of, randomization
* 3\. Drug medication prior to randomization or expected to be treated by medicines during the study period.
* 4\. Currently receiving or expected to receive immunosuppressive therapy during the study period.
* 5\. Renal impairment or hepatic dysfunction
* 6\. Nervous system disease or neuromuscular disease
* 7\. Prior history of a suspected or actual acute life-threatening event
* 8\. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
* 9\. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
* 10.Receipt of RSV vaccine or mAb
0 Years
1 Year
ALL
Yes
Sponsors
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Zhuhai Trinomab Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hanmin Liu, MD
Role: PRINCIPAL_INVESTIGATOR
West China Second Hospital, Sichuan University
Enmei Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Chongqing Medical University
Ying Wang
Role: STUDY_DIRECTOR
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Children's Hospital Capital Institute Pediatrics
Beijing, Beijing Municipality, China
Jiangjin Central Hospital
Chongqing, Chongqing Municipality, China
Xiamen maternal and Child Health Hospital
Xiamen, Fujian, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangdong, China
Guangdong Maternal and Child Health Care Hospital
Guangzhou, Guangdong, China
University of Chinese Academy of Sciense Shenzhen Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
LiuZhou People's Hospital
Liuzhou, Guangxi, China
Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
HaiNan Women and Children's Medical Center
Haikou, Hainan, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of HeBei Medical University (HBMU)
Shijiazhuang, Hebei, China
Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
Tangshan, Hebei, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Xinxiang First People's Hospital
Xinxiang, Henan, China
Henan (Zhengzhou) Children's Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
The First People'S Hospital of Changde City
Changde, Hunan, China
The Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Hospital University of South China
Hengyang, Hunan, China
Loudi Central Hospital
Loudi, Hunan, China
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Children's Hospital Affiliated to Shandong University
Jinan, Shandong, China
The affiliated children'shospital fudan university
Shanghai, Shanghai Municipality, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Children's Hospital of Chongqing Medical University
Chongqing, Sichuan, China
Mianyang Peoples Hospital
Mianyang, Sichuan, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Ningbo Women&Children's Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTR20232792
Identifier Type: OTHER
Identifier Source: secondary_id
TNM001-301
Identifier Type: -
Identifier Source: org_study_id
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