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Breakthrough shot shields babies from deadly RSV

NCT ID NCT05110261

Prevention Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 single dose of nirsevimab, a lab-made antibody, in 800 healthy preterm and term infants in China to see if it could prevent serious lung infections caused by RSV. The goal was to reduce doctor visits and hospital stays during the RSV season. Results showed the treatment was safe and effective at lowering the risk of RSV-related illness.

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

800 people

The number who actually took part.

Started

Nov 2021

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. Healthy Chinese preterm and term infants in their first year of life and born ≥ 29 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible) 2. Infants who are entering their first RSV season at the time of screening 3. Written informed consent and any locally required authorization obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations 4. Subject's parent(s)/legal representative(s) able to understand and comply with the requirements of the protocol including follow-up visits as judged by the Investigator 5. Subject is available to complete the follow up period, which will be approximately 1 year after receipt of investigational product Exclusion Criteria: 1. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to investigational product administration 2. Any history of LRTI or active LRTI prior to, or at the time of, randomization 3. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization 4. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the Investigator 5. Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the Investigator) 6. History of receipt of blood products, or immunoglobulin products, or expected receipt through the duration of the study 7. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization 8. Known renal impairment 9. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 10. History of CLD/bronchopulmonary dysplasia 11. Clinically significant congenital anomaly of the respiratory tract 12. CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect) 13. Chronic seizure, or evolving or unstable neurologic disorder 14. Prior history of a suspected or actual acute life-threatening event 15. Known immunodeficiency, including human immunodeficiency virus (HIV) 16. Mother with HIV infection (unless the child has been proven to be not infected) 17. Any known allergy or history of allergic reaction to immunoglobulin products, blood products, or other foreign proteins, or history of allergic reaction 18. Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination 19. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) or anticipated use during the study 20. Receipt of any investigational product 21. Concurrent enrollment in another interventional study 22. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of study results 23. Children of employees of the Sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

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Conditions

The condition(s) this trial relates to.

lower respiratory tract disorder respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

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

Lower respiratory tract infection

Contacts and locations

Locations

  • Research Site

    Beijing, 100191, China

  • Research Site

    Changde, 415000, China

  • Research Site

    Changsha, 410005, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Chengdu, 610000, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Guangzhou, 510120, China

  • Research Site

    Guangzhou, 510150, China

  • Research Site

    Guangzhou, 510280, China

  • Research Site

    Hangzhou, 310006, China

  • Research Site

    Hangzhou, 310013, China

  • Research Site

    Jiaxing, 314000, China

  • Research Site

    Kunming, 650101, China

  • Research Site

    Langfang, 065000, China

  • Research Site

    Linfen, 041099, China

  • Research Site

    Linfen, 41081, China

  • Research Site

    Nanjing, 210009, China

  • Research Site

    Ningbo, 315012, China

  • Research Site

    Sanmenxia, 472000, China

  • Research Site

    Sanya, 572000, China

  • Research Site

    Shantou, 515041, China

  • Research Site

    Shaoxing, 311800, China

  • Research Site

    Shenzhen, 518106, China

  • Research Site

    Suzhou, 215002, China

  • Research Site

    Tangshan, 63003, China

  • Research Site

    Tianjin, 300201, China

  • Research Site

    Wenzhou, 325027, China

  • Research Site

    Xinxiang, 453000, China

  • Research Site

    Zhengzhou, 450018, China

  • Research Site

    Zhongshan, 528400, China

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