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Breakthrough RSV shot shields vulnerable babies

NCT ID NCT06710925

Prevention Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called TNM001 to prevent severe RSV lung infections in high-risk infants under 1 year old. About 201 babies received either the antibody or a placebo, and were monitored for 270 days. The goal was to see if the antibody could safely reduce serious breathing problems caused by RSV.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

315 people

The number who actually took part.

Started

Nov 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 weeks to 12 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus infections

Contacts and locations

Locations

  • Children's Hospital of Chongqing Medical University

    Chongqing, Sichuan, 404100, China

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610000, China

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Other studies related to the condition(s) this trial covers.