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New RSV shot protects thousands of babies from severe illness

NCT ID NCT06325332

Prevention Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 how well a single dose of BEYFORTUS (nirsevimab) protects infants from serious RSV infections that require a doctor visit or hospital stay. Researchers followed nearly 50,000 babies during their first RSV season. The goal was to see if the shot reduces cases of RSV-related lung infections and other medical visits.

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

49,680 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 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.

Who is studied

The study is an observational, retrospective cohort study designed to evaluate the effectiveness of nirsevimab to prevent RSV-confirmed respiratory-related medical encounters and health care utilization in infants entering their first RSV season compared to no treatment in the United States. The source population is infants ≥ 37 weeks gestational age and aged 0 to 12 months (calendar age) entering their first RSV season and without significant medical history. There is also a high-risk infant population with infants \< 37 WGA and aged 0 to 12 months (calendar age), entering their first RSV season and infants ≥ 37 weeks with significant medical history diagnosed at birth up to the end of the observation period (ie, 30 April 2024). The study will aim to enroll approximately 33,000 infants.

Ages

0 days 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: * The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01 April 2023 for Cohort 1 and Cohort 2. * Eligible to receive nirsevimab as defined by the product indication. * KPNC infants entering their first RSV season. Exclusion Criteria: * Mother was administered an RSV vaccine during her pregnancy with the infant participant. * Mother of infant participant was not a KPNC member during pregnancy. * Mother did not deliver the infant participant at a KPNC facility. * Infant receipt of other RSV pre-exposure prophylaxis (ie, Palivizumab). Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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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

Contacts and locations

Locations

  • Kaiser Permanente Northern California: Site number 0001

    Oakland, California, 94612, United States

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