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
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: placeboBiological: TNM001
- Registration Number
- NCT06083623
- Lead Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants \[gestational age (GA)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2250
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- Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.
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- Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
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- History of RSV infection or active RSV infection prior to, or at the time of, randomization
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- Drug medication prior to randomization or expected to be treated by medicines during the study period.
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- Currently receiving or expected to receive immunosuppressive therapy during the study period.
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- Renal impairment or hepatic dysfunction
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- Nervous system disease or neuromuscular disease
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- Prior history of a suspected or actual acute life-threatening event
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- Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
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- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - TNM001 TNM001 -
- Primary Outcome Measures
Name Time Method Incidence of medically attended LRTI due to RT-PCR confirmed RSV 150 days post dose
- Secondary Outcome Measures
Name Time Method Incidence of hospitalization due to RT-PCR confirmed RSV LRTI 150 days post dose Serum level of neutralizing antibody to RSV 240 days post dose Serum concentration of single dose TNM001 at pre-specified timepoints 240 days post dose Occurrence of adverse events (AEs) 240 days post dose Change in heart rate (beats per minute) 240 days post dose Change in respiratory rate (breaths per min) 240 days post dose Change in body temperature (celsius) 240 days post dose Number of subjects with clinical significant abnormality in physical examinations 240 days post dose Positive rate of anti-drug antibody (ADA) to TNM001 in serum 240 days post dose Change in blood pressure (mmHg) 240 days post dose
Trial Locations
- Locations (39)
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangdong, Guangdong, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Children's Hospital Capital Institute Pediatrics
🇨🇳Beijing, Beijing, China
Jiangjin Central Hospital
🇨🇳Chongqing, Chongqing, China
Xiamen maternal and Child Health Hospital
🇨🇳Xiamen, Fujian, China
University of Chinese Academy of Sciense Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Guangdong Maternal and Child Health Care Hospital
🇨🇳Guangzhou, 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
🇨🇳Shijia Zhuang, Hebei, China
The Second Hospital of HeBei Medical University (HBMU)
🇨🇳Shijia Zhuang, 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 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
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Loudi Central Hospital
🇨🇳Loudi, Hunan, China
Jiangxi Maternal and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Children's Hospital Affiliated to Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Shaoyang University
🇨🇳Shaoyang, Hunan, China
Linfen Central Hospital
🇨🇳Linfen, Shanxi, China
Linfen People's Hospital
🇨🇳Linfen, Shanxi, China
The affiliated children'shospital fudan university
🇨🇳Shanghai, Shanghai, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, 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
Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China
Ningbo Women&Children's Hospital
🇨🇳Ningbo, Zhejiang, China