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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

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研究单位: [1]West China Second Hospital, Sichuan University [2]Children's Hospital of Chongqing Medical University [3]Zhuhai Trinomab Pharmaceutical Co., Ltd. [4][5Peking University Third Hospital,Beijing,Beijing,China,100000 [5]Children''s Hospital Capital Institute Pediatrics,Beijing,Beijing,China,100020 [6]Jiangjin Central Hospital,Chongqing,Chongqing,China,400000 [7]Xiamen maternal and Child Health Hospital,Xiamen,Fujian,China,361003 [8]The Third Affiliated Hospital of Guangzhou Medical University,Guangdong,Guangdong,China,510150 [9]Guangdong Maternal and Child Health Care Hospital,Guangzhou,Guangdong,China,511442 [10]University of Chinese Academy of Sciense Shenzhen Hospital,Shenzhen,Guangdong,China,518000 [11]Affiliated Hospital of Guilin Medical University,Guilin,Guangxi,China,541001 [12]LiuZhou People''s Hospital,Liuzhou,Guangxi,China,545006 [13]Maternity and Child Health Care of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China,530002 [14]HaiNan Women and Children''s Medical Center,Haikou,Hainan,China,570312 [15]Hebei Petro China Central Hospital,Langfang,Hebei,China,065000 [16]The Fourth Hospital of Hebei Medical University,Shijia Zhuang,Hebei,China,050000 [17]The Second Hospital of HeBei Medical University (HBMU),Shijia Zhuang,Hebei,China,050000 [18]Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital,Tangshan,Hebei,China,063000 [19]Sanmenxia Central Hospital,Sanmenxia,Henan,China,472000 [20]Xinxiang First People''s Hospital,Xinxiang,Henan,China,453000 [21]Henan (Zhengzhou) Children''s Hospital,Zhengzhou,Henan,China,450052 [22]Renmin Hospital of Wuhan University,Wuhan,Hubei,China,430060 [23]The Central Hospital of Wuhan,Wuhan,Hubei,China,430060 [24]The First People''S Hospital of Changde City,Changde,Hunan,China,415000 [25]The Maternal and Child Health Hospital of Hunan Province,Changsha,Hunan,China,410008 [26]Xiangya Hospital Central South University,Changsha,Hunan,China,410008 [27]The Third Xiangya Hospital of Central South University,Changsha,Hunan,China,410013 [28]The Second Hospital University of South China,Hengyang,Hunan,China,421001 [29]Loudi Central Hospital,Loudi,Hunan,China,417099 [30]The First Affiliated Hospital of Shaoyang University,Shaoyang,Hunan,China,422000 [31]Jiangxi Maternal and Child Health Hospital,Nanchang,Jiangxi,China,330000 [32]Children''s Hospital Affiliated to Shandong University,Jinan,Shandong,China,250022 [33]The affiliated children''shospital fudan university,Shanghai,Shanghai,China,201102 [34]Linfen Central Hospital,Linfen,Shanxi,China,041000 [35]Linfen People''s Hospital,Linfen,Shanxi,China,041000 [36]Yuncheng Central Hospital,Yuncheng,Shanxi,China,044000 [37]Chengdu Women''s and Children''s Central Hospital,Chengdu,Sichuan,China,610000 [38]West China Second University Hospital, Sichuan University,Chengdu,Sichuan,China,610000 [39]Children''s Hospital of Chongqing Medical University,Chongqing,Sichuan,China,404100 [40]Mianyang Peoples Hospital,Mianyang,Sichuan,China,621000 [41]Affiliated Hangzhou First People''s Hospital, Zhejiang University School of Medicine/Hangzhou First People''s Hospital,Hangzhou,Zhejiang,China,310006 [42]Ningbo Women&Children''s Hospital,Ningbo,Zhejiang,China,315012

研究目的:
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

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