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Respiratory Syncytial Virus InfectionsPhase 2/3NCT06083623

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 Phase 2/3 study testing TNM001 in people with Respiratory Syncytial Virus Infections, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 39 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 years to 1 yearHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
TNM001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,282 participants
Where
39 sitesChina
Study dates
11 Sep 2023to 5 Nov 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years to 1 year
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

China39 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Children's Hospital Capital Institute Pediatrics

    Beijing, Beijing Municipality, 100020

  • The First People'S Hospital of Changde City

    Changde, Hunan, 415000

  • The Maternal and Child Health Hospital of Hunan Province

    Changsha, Hunan, 410008

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610000

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • Jiangjin Central Hospital

    Chongqing, Chongqing Municipality, 400000

  • Children's Hospital of Chongqing Medical University

    Chongqing, Sichuan, 404100

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangdong, Guangdong, 510150

  • Guangdong Maternal and Child Health Care Hospital

    Guangzhou, Guangdong, 511442

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

  • HaiNan Women and Children's Medical Center

    Haikou, Hainan, 570312

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • The Second Hospital University of South China

    Hengyang, Hunan, 421001

  • Children's Hospital Affiliated to Shandong University

    Jinan, Shandong, 250022

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000

  • Linfen Central Hospital

    Linfen, Shanxi, 041000

  • Linfen People's Hospital

    Linfen, Shanxi, 041000

  • LiuZhou People's Hospital

    Liuzhou, Guangxi, 545006

  • Loudi Central Hospital

    Loudi, Hunan, 417099

  • Mianyang Peoples Hospital

    Mianyang, Sichuan, 621000

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330000

  • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530002

  • Ningbo Women&Children's Hospital

    Ningbo, Zhejiang, 315012

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

  • The affiliated children'shospital fudan university

    Shanghai, Shanghai Municipality, 201102

  • The First Affiliated Hospital of Shaoyang University

    Shaoyang, Hunan, 422000

  • University of Chinese Academy of Sciense Shenzhen Hospital

    Shenzhen, Guangdong, 518000

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Second Hospital of HeBei Medical University (HBMU)

    Shijiazhuang, Hebei, 050000

  • Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital

    Tangshan, Hebei, 063000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430060

  • Xiamen maternal and Child Health Hospital

    Xiamen, Fujian, 361003

  • Xinxiang First People's Hospital

    Xinxiang, Henan, 453000

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

  • Henan (Zhengzhou) Children's Hospital

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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

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.

Read the 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.

Being tested
TNM001, placebo
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNM001Biological

    single dose intramuscular injection

  • placeboBiological

    single dose intramuscular injection

Study groups in NCT06083623
Study groupRoleWhat they receive
TNM001ExperimentalNot described
Receives: Biological: TNM001
PlaceboPlacebo comparatorNot described
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of medically attended LRTI due to RT-PCR confirmed RSV

    Measured: 150 days post dose

Secondary outcomes (10)

  1. Incidence of hospitalization due to RT-PCR confirmed RSV LRTI

    Measured: 150 days post dose

  2. Occurrence of adverse events (AEs)

    Measured: 240 days post dose

  3. Change in body temperature (celsius)

    Measured: 240 days post dose

  4. Change in blood pressure (mmHg)

    Measured: 240 days post dose

  5. Change in heart rate (beats per minute)

    Measured: 240 days post dose

  6. Change in respiratory rate (breaths per min)

    Measured: 240 days post dose

  7. Number of subjects with clinical significant abnormality in physical examinations

    Measured: 240 days post dose

  8. Serum concentration of single dose TNM001 at pre-specified timepoints

    Measured: 240 days post dose

  9. Serum level of neutralizing antibody to RSV

    Measured: 240 days post dose

  10. Positive rate of anti-drug antibody (ADA) to TNM001 in serum

    Measured: 240 days post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start11 Sep 2023
  3. Primary completion16 Jun 2025
  4. Study completion5 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06083623
Sponsor's protocol ID
TNM001-301
Other IDs
CTR20232792
Status last verified
Jan 2026
First submitted
10 Sep 2023
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TNM001 in people with Respiratory Syncytial Virus Infections, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of medically attended LRTI due to RT-PCR confirmed RSV (time frame: 150 days post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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