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.