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
A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age
2 other identifiers
interventional
2,282
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2023
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2025
CompletedMarch 5, 2026
January 1, 2026
1.8 years
September 10, 2023
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
150 days post dose
Secondary Outcomes (10)
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
150 days post dose
Occurrence of adverse events (AEs)
240 days post dose
Change in body temperature (celsius)
240 days post dose
Change in blood pressure (mmHg)
240 days post dose
Change in heart rate (beats per minute)
240 days post dose
- +5 more secondary outcomes
Study Arms (2)
TNM001
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization
- \. History of RSV infection or active RSV infection prior to, or at the time of, randomization
- \. Drug medication prior to randomization or expected to be treated by medicines during the study period.
- \. Currently receiving or expected to receive immunosuppressive therapy during the study period.
- \. Renal impairment or hepatic dysfunction
- \. Nervous system disease or neuromuscular disease
- \. Prior history of a suspected or actual acute life-threatening event
- \. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
- \. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
- Receipt of RSV vaccine or mAb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Children's Hospital Capital Institute Pediatrics
Beijing, Beijing Municipality, 100020, China
Jiangjin Central Hospital
Chongqing, Chongqing Municipality, 400000, China
Xiamen maternal and Child Health Hospital
Xiamen, Fujian, 361003, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangdong, 510150, China
Guangdong Maternal and Child Health Care Hospital
Guangzhou, Guangdong, 511442, China
University of Chinese Academy of Sciense Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
LiuZhou People's Hospital
Liuchow, Guangxi, 545006, China
Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530002, China
HaiNan Women and Children's Medical Center
Haikou, Hainan, 570312, China
Hebei Petro China Central Hospital
Langfang, Hebei, 065000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Hospital of HeBei Medical University (HBMU)
Shijiazhuang, Hebei, 050000, China
Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
Tangshan, Hebei, 063000, China
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000, China
Xinxiang First People's Hospital
Xinxiang, Henan, 453000, China
Henan (Zhengzhou) Children's Hospital
Zhengzhou, Henan, 450052, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430060, China
The First People'S Hospital of Changde City
Changde, Hunan, 415000, China
The Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, 410008, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The Second Hospital University of South China
Hengyang, Hunan, 421001, China
Loudi Central Hospital
Loudi, Hunan, 417099, China
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan, 422000, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330000, China
Children's Hospital Affiliated to Shandong University
Jinan, Shandong, 250022, China
The affiliated children'shospital fudan university
Shanghai, Shanghai Municipality, 201102, China
Linfen Central Hospital
Linfen, Shanxi, 041000, China
Linfen People's Hospital
Linfen, Shanxi, 041000, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610000, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610000, China
Children's Hospital of Chongqing Medical University
Chongqing, Sichuan, 404100, China
Mianyang Peoples Hospital
Mianyang, Sichuan, 621000, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
Ningbo Women&Children's Hospital
Ningbo, Zhejiang, 315012, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanmin Liu, MD
West China Second Hospital, Sichuan University
- PRINCIPAL INVESTIGATOR
Enmei Liu, MD
Children's Hospital of Chongqing Medical University
- STUDY DIRECTOR
Ying Wang
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2023
First Posted
October 16, 2023
Study Start
September 11, 2023
Primary Completion
June 16, 2025
Study Completion
November 5, 2025
Last Updated
March 5, 2026
Record last verified: 2026-01