> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-to-evaluate-the-efficacy-and-safety-of-tnm001-for-b893901e-d498-41fd-975b-7aa3dbc11fdd > Record changed: 2026-11-04 # 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 NCT06083623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Participants 2,282 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Lead sponsor Zhuhai Trinomab Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Start date 2023-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Dates **Completion date** 2025-11-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **First posted** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Registry last updated** 2026-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Primary completion date** 2025-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Start date** 2023-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Size and sites **Actual participants** 2,282 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Participants** 2,282 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Randomisation ratio** 2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Lead sponsor** Zhuhai Trinomab Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Identifiers **Registry ID** NCT06083623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **ClinicalTrials.gov ID** NCT06083623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Outcomes ### Primary outcomes 1. Incidence of medically attended LRTI due to RT-PCR confirmed RSV Timeframe: 150 days post dose ### Secondary outcomes 1. Incidence of hospitalization due to RT-PCR confirmed RSV LRTI Timeframe: 150 days post dose 2. Occurrence of adverse events (AEs) Timeframe: 240 days post dose 3. Change in body temperature (celsius) Timeframe: 240 days post dose 4. Change in blood pressure (mmHg) Timeframe: 240 days post dose 5. Change in heart rate (beats per minute) Timeframe: 240 days post dose 6. Change in respiratory rate (breaths per min) Timeframe: 240 days post dose 7. Number of subjects with clinical significant abnormality in physical examinations Timeframe: 240 days post dose 8. Serum concentration of single dose TNM001 at pre-specified timepoints Timeframe: 240 days post dose 9. Serum level of neutralizing antibody to RSV Timeframe: 240 days post dose 10. Positive rate of anti-drug antibody (ADA) to TNM001 in serum Timeframe: 240 days post dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 0 Years **Maximum age** 1 Year **Healthy volunteers** Yes ### Inclusion criteria - 1\. 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. ### Exclusion criteria - 1\. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization - 2\. History of RSV infection or active RSV infection prior to, or at the time of, randomization - 3\. Drug medication prior to randomization or expected to be treated by medicines during the study period. - 4\. Currently receiving or expected to receive immunosuppressive therapy during the study period. - 5\. Renal impairment or hepatic dysfunction - 6\. Nervous system disease or neuromuscular disease - 7\. Prior history of a suspected or actual acute life-threatening event - 8\. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded. - 9\. 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Sites - Peking University Third HospitalBeijing, China - Children's Hospital Capital Institute PediatricsBeijing, China - Jiangjin Central HospitalChongqing, China - Xiamen maternal and Child Health HospitalXiamen, China - The Third Affiliated Hospital of Guangzhou Medical UniversityGuangdong, China - Guangdong Maternal and Child Health Care HospitalGuangzhou, China - University of Chinese Academy of Sciense Shenzhen HospitalShenzhen, China - Affiliated Hospital of Guilin Medical UniversityGuilin, China - LiuZhou People's HospitalLiuzhou, China - Maternity and Child Health Care of Guangxi Zhuang Autonomous RegionNanning, China - HaiNan Women and Children's Medical CenterHaikou, China - Hebei Petro China Central HospitalLangfang, China - The Fourth Hospital of Hebei Medical UniversityShijiazhuang, China - The Second Hospital of HeBei Medical University (HBMU)Shijiazhuang, China - Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health HospitalTangshan, China - Sanmenxia Central HospitalSanmenxia, China - Xinxiang First People's HospitalXinxiang, China - Henan (Zhengzhou) Children's HospitalZhengzhou, China - Renmin Hospital of Wuhan UniversityWuhan, China - The Central Hospital of WuhanWuhan, China - The First People'S Hospital of Changde CityChangde, China - The Maternal and Child Health Hospital of Hunan ProvinceChangsha, China - Xiangya Hospital Central South UniversityChangsha, China - The Third Xiangya Hospital of Central South UniversityChangsha, China - The Second Hospital University of South ChinaHengyang, China And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## References ### Other registry identifiers - CTR20232792 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06083623) ## Related records ### Drugs (1) - [Siltartoxatug](https://trialight.com/data/asset/siltartoxatug-c935a329-850a-4bca-9a9e-b60c512ec180.md) ### Lead sponsors (1) - [Zhuhai Trinomab Pharmaceutical Co., Ltd.](https://trialight.com/data/company/zhuhai-trinomab-pharmaceutical-co-ltd-21fa3ff9-e37b-4a42-9c17-bf5023054add.md) ### Conditions (1) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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