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
Phase
Phase 2/Phase 3
Recruitment status
Completed
Participants
2,282
Lead sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Start date
2023-09-11
Number of sites
- 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.
- 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
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2/Phase 3
- Study type
- Interventional
- Completion date
- 2025-11-05
- First posted
- 2023-10-16
- Registry last updated
- 2026-03-05
- Primary completion date
- 2025-06-16
- Start date
- 2023-09-11
- Actual participants
- 2,282
- Participants
- 2,282
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06083623
- ClinicalTrials.gov ID
- NCT06083623
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Timeframe: 150 days post dose
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Timeframe: 150 days post dose
Occurrence of adverse events (AEs)
Timeframe: 240 days post dose
Change in body temperature (celsius)
Timeframe: 240 days post dose
Change in blood pressure (mmHg)
Timeframe: 240 days post dose
Change in heart rate (beats per minute)
Timeframe: 240 days post dose
Change in respiratory rate (breaths per min)
Timeframe: 240 days post dose
Number of subjects with clinical significant abnormality in physical examinations
Timeframe: 240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints
Timeframe: 240 days post dose
Serum level of neutralizing antibody to RSV
Timeframe: 240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum
Timeframe: 240 days post dose
Sources for outcomes
- Sex
- All
- Age groups
- Children
- Minimum age
- 0 Years
- Maximum age
- 1 Year
- Healthy volunteers
- Yes
- 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.
- 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
- 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
Other registry identifiers
- CTR20232792
Sources for references
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Respiratory syncytial virus infectious disease Primary condition