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

March 3, 2026 updated by: Zhuhai Trinomab Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2282

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100000
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100020
        • Children's Hospital Capital Institute Pediatrics
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400000
        • Jiangjin Central Hospital
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Xiamen Maternal and Child Health Hospital
    • Guangdong
      • Guangdong, Guangdong, China, 510150
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 511442
        • Guangdong Maternal and Child Health Care Hospital
      • Shenzhen, Guangdong, China, 518000
        • University of Chinese Academy of Sciense Shenzhen Hospital
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Affiliated Hospital of Guilin Medical University
      • Liuchow, Guangxi, China, 545006
        • Liuzhou People's Hospital
      • Nanning, Guangxi, China, 530002
        • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
    • Hainan
      • Haikou, Hainan, China, 570312
        • Hainan Women and Children's Medical Center
    • Hebei
      • Langfang, Hebei, China, 065000
        • Hebei Petro China Central Hospital
      • Shijiazhuang, Hebei, China, 050000
        • The Fourth Hospital of Hebei Medical University
      • Shijiazhuang, Hebei, China, 050000
        • The Second Hospital of HeBei Medical University (HBMU)
      • Tangshan, Hebei, China, 063000
        • Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
    • Henan
      • Sanmenxia, Henan, China, 472000
        • Sanmenxia Central Hospital
      • Xinxiang, Henan, China, 453000
        • Xinxiang First People's Hospital
      • Zhengzhou, Henan, China, 450052
        • Henan (Zhengzhou) Children's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430060
        • The Central Hospital of Wuhan
    • Hunan
      • Changde, Hunan, China, 415000
        • The First People's Hospital of Changde City
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410013
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China, 410008
        • The Maternal and Child Health Hospital of Hunan Province
      • Hengyang, Hunan, China, 421001
        • The Second Hospital University of South China
      • Loudi, Hunan, China, 417099
        • Loudi Central Hospital
      • Shaoyang, Hunan, China, 422000
        • The First Affiliated Hospital of Shaoyang University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Jiangxi Maternal and Child Health Hospital
    • Shandong
      • Jinan, Shandong, China, 250022
        • Children's Hospital Affiliated to Shandong University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201102
        • The affiliated children'shospital fudan university
    • Shanxi
      • Linfen, Shanxi, China, 041000
        • Linfen People's Hospital
      • Linfen, Shanxi, China, 041000
        • Linfen Central Hospital
      • Yuncheng, Shanxi, China, 044000
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Chengdu Women's and Children's Central Hospital
      • Chengdu, Sichuan, China, 610000
        • West China Second University Hospital, Sichuan University
      • Chongqing, Sichuan, China, 404100
        • Children's Hospital of Chongqing Medical University
      • Mianyang, Sichuan, China, 621000
        • Mianyang Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
      • Ningbo, Zhejiang, China, 315012
        • Ningbo Women&Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Biological: placebo
single dose intramuscular injection
Experimental: TNM001
Biological: TNM001
single dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of medically attended LRTI due to RT-PCR confirmed RSV
Time Frame: 150 days post dose
150 days post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI
Time Frame: 150 days post dose
150 days post dose
Occurrence of adverse events (AEs)
Time Frame: 240 days post dose
240 days post dose
Change in body temperature (celsius)
Time Frame: 240 days post dose
240 days post dose
Change in blood pressure (mmHg)
Time Frame: 240 days post dose
240 days post dose
Change in heart rate (beats per minute)
Time Frame: 240 days post dose
240 days post dose
Change in respiratory rate (breaths per min)
Time Frame: 240 days post dose
240 days post dose
Number of subjects with clinical significant abnormality in physical examinations
Time Frame: 240 days post dose
240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints
Time Frame: 240 days post dose
240 days post dose
Serum level of neutralizing antibody to RSV
Time Frame: 240 days post dose
240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum
Time Frame: 240 days post dose
240 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNM001-301
  • CTR20232792 (Other Identifier: ENTER FOR DRUG EVALUATION, NMPA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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