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New RSV shot shows promise in protecting infants from severe lung infections

NCT ID NCT06083623

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an injection called TNM001 in over 2,200 babies under 1 year old to see if it could prevent serious lung infections caused by RSV. The goal was to reduce the number of babies who get sick enough to need medical care. The study compared the shot to a placebo to check both safety and effectiveness.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

2,282 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 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 years to 1 year

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\. 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

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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

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

    Hangzhou, Zhejiang, 310006, China

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001, China

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610000, China

  • Children's Hospital Affiliated to Shandong University

    Jinan, Shandong, 250022, China

  • Children's Hospital Capital Institute Pediatrics

    Beijing, Beijing Municipality, 100020, China

  • Children's Hospital of Chongqing Medical University

    Chongqing, Sichuan, 404100, China

  • Guangdong Maternal and Child Health Care Hospital

    Guangzhou, Guangdong, 511442, China

  • HaiNan Women and Children's Medical Center

    Haikou, Hainan, 570312, China

  • Hebei Petro China Central Hospital

    Langfang, Hebei, 065000, China

  • Henan (Zhengzhou) Children's Hospital

    Zhengzhou, Henan, 450052, China

  • Jiangjin Central Hospital

    Chongqing, Chongqing Municipality, 400000, China

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330000, China

  • Linfen Central Hospital

    Linfen, Shanxi, 041000, China

  • Linfen People's Hospital

    Linfen, Shanxi, 041000, China

  • LiuZhou People's Hospital

    Liuzhou, Guangxi, 545006, China

  • Loudi Central Hospital

    Loudi, Hunan, 417099, China

  • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530002, China

  • Mianyang Peoples Hospital

    Mianyang, Sichuan, 621000, China

  • Ningbo Women&Children's Hospital

    Ningbo, Zhejiang, 315012, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060, China

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000, China

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

    Tangshan, Hebei, 063000, China

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430060, China

  • The First Affiliated Hospital of Shaoyang University

    Shaoyang, Hunan, 422000, China

  • The First People'S Hospital of Changde City

    Changde, Hunan, 415000, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • The Maternal and Child Health Hospital of Hunan Province

    Changsha, Hunan, 410008, China

  • The Second Hospital University of South China

    Hengyang, Hunan, 421001, China

  • The Second Hospital of HeBei Medical University (HBMU)

    Shijiazhuang, Hebei, 050000, China

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangdong, Guangdong, 510150, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • The affiliated children'shospital fudan university

    Shanghai, Shanghai Municipality, 201102, China

  • University of Chinese Academy of Sciense Shenzhen Hospital

    Shenzhen, Guangdong, 518000, China

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan, 610000, China

  • Xiamen maternal and Child Health Hospital

    Xiamen, Fujian, 361003, China

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Xinxiang First People's Hospital

    Xinxiang, Henan, 453000, China

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000, China

More trials for these conditions

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