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
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.
