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New RSV shot shows promise in protecting babies

NCT ID NCT07382219

Prevention Sponsor: Han Tongyan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether a single shot of nirsevimab (Beyfortus) can prevent RSV and other respiratory infections in infants under 1 year old. Researchers reviewed medical records from 816 babies at seven hospitals in China, comparing those who got the shot to those who did not. The goal was to see if the shot reduced hospitalizations for RSV and other respiratory illnesses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nirsevimab (Beyfortus), a monoclonal antibody given as a single shot
What this could lead to
If effective, nirsevimab could become a standard preventive option to protect infants from severe RSV infections during their first season.
What could go wrong
This is a retrospective study, not a randomized trial, so results may be influenced by unmeasured factors. Effectiveness may vary in different populations or settings.

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.

Participants

816 people

The number who actually took part.

Started

Aug 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025

Ages

Up 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: Infants aged ≤ 1 year (including preterm infants) entering their first RSV season. Exclusion Criteria: 1. Prior or active RSV infection. 2. Prior RSV immunization (maternal vaccine or monoclonal antibody).

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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.

Lower respiratory tract infections RSV infections

Contacts and locations

Locations

  • Beijing Children's Hospital

    Beijing, 100045, China

  • Beijing Luhe Hospital

    Beijing, 101149, China

  • Inner Mongolia Maternity and Child Health Care Hospital

    Hohhot, Inner Mongolia, 010000, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Shenzhen Maternity & Child Healthcare Hospital

    Shenzhen, 518000, China

  • Women and Children's Hospital

    Qingdao, Shandong, 266000, China

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092, China

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