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Respiratory Syncytial Virus InfectionsPhase 3NCT06710925

A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants

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

This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. Read more about this study

Who is it for?
Ages 0 weeks to 12 monthsHealthy 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
315 participants
Where
2 sitesChina
Study dates
28 Nov 2024to 14 Dec 2025
Phase
Phase 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 weeks to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
  • 2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection.
  • 3.Subject is available to complete the follow-up period.

Who cannot join

  • 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
  • 2. History of RSV infection
  • 3. Being hospitalized at the time of randomization
  • 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. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
  • 8. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
  • 9.Receipt of RSV vaccine or mAb
  • 10.Receiving blood products before randomization

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610000

  • Children's Hospital of Chongqing Medical University

    Chongqing, Sichuan, 404100

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Monoclonal Antibody TNM001 Injection Against Respiratory Syncytial Virus in High-risk Infants

This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 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 NCT06710925
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

Timeline

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

  1. First posted29 Nov 2024
  2. Study start28 Nov 2024
  3. Primary completion27 Jul 2025
  4. Study completion14 Dec 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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710925
Sponsor's protocol ID
TNM001-302
Status last verified
Mar 2026
First submitted
26 Nov 2024
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 3 study testing TNM001 in people with Respiratory Syncytial Virus Infections, run by Zhuhai Trinomab Pharmaceutical Co., Ltd. at 2 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 3 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 2 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 phase mean?

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 NCT06710925.

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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