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Massive french study to test if RSV antibody shot stops childhood wheezing

NCT ID NCT07317141

Prevention Sponsor: Hospices Civils de Lyon 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will follow over 200,000 infants in France to see if early immunization with nirsevimab, an antibody against RSV, reduces wheezing episodes in preschool years. Researchers will compare hospitalization rates for wheezing between immunized and non-immunized children. The goal is to understand if preventing RSV early can have long-term respiratory benefits.

What this could mean

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

Active substance
nirsevimab (a monoclonal antibody against RSV)
What this could lead to
If successful, this could show that giving nirsevimab early in life reduces wheezing and may lower the risk of asthma in later childhood.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. The study has not started yet, and long-term benefits are uncertain.

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

About 218,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

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

The study cohorts will combine individual data from the National Health Data System (SNDS), covering the entire French population, and hospitalization data from the French Medicalization of Information Systems Program (PMSI). The SNDS includes socio-demographic data, outpatient reimbursements (including prescriptions), and inpatient care with diagnoses and procedures. The PMSI provides details on hospital stays, diagnoses, and procedures. All data are linked via unique anonymous identifiers. With an average of 60,000 births per month and a 20% exclusion rate, investigators estimate 576,000 eligible patients, exceeding the required sample size (218,000: 70,000 exposed, 148,000 non-exposed).

Ages

Up to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * \- Exposed group of children: all children born between 06/02/2023 and 31/01/2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied. * Unexposed group of children: all children born between 06/02/2023 and 31/01/2024 and who did not receive nirsevimab Exclusion Criteria: * \- Infants born in Overseas Departments and Territories (Guadeloupe, Martinique, Guyana, La Réunion, Mayotte, Saint-Pierre-et-Miquelon, French Polynesia, Nouvelle-Calédonie, Wallis-et-Futuna, French Southern and Antarctic Lands, Clipperton island) * Same-sex twins, as they cannot be differentiated in the French Medicalization of Information Systems Program (PMSI) * Infants born between 06/02/2023 and 31/01/2024 in a maternity unit that has not reported data on the immunization with nirsevimab * Infants whose mother had been vaccinated against RSV during pregnancy * Infants who received palivizumab immunization * Date of nirsevimab immunization not provided * Infants hospitalized for wheezing or RSV+ lower respiratory tract infection before receiving nirsevimab * Infants who were immunized after 12 months of age for outcomes collected between 2 and 6 years old * Infants who were immunized after 6 months of age for outcomes collected during the second year of life

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Conditions

The condition(s) this trial relates to.

childhood onset asthma

As listed by the trial registrant

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

Asthma childhood Infant wheeze Preschool age children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, 69677, France

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