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Double defense against RSV: could Mom's vaccine plus Baby's shot be the key?

NCT ID NCT07232706

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving both an RSV vaccine to pregnant women and an antibody shot to their babies prevents RSV infection better than giving only the baby shot. About 1000 pregnant women in France will be randomly assigned to one of two groups. The goal is to see if the combined approach reduces RSV cases in infants during their first year of life.

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

About 1,000 people

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

Started

May 2026

Expected to finish

May 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.

Ages

18 years and older

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. Pregnant women 2. Provide informed consent prior to study enrolment 3. Willing and able (in the site investigator's opinion) to comply with all study requirements 4. More than 18 years of age 5. Between 32 and 36 weeks of gestation 6. Able to read and complete the eHealth questionnaire in French or English 7. Willing to receive maternal vaccine in pregnancy, if allocated 8. Willing for the baby to receive infant nirsevimab 9. Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial 10. Affiliated to social security regime or an equivalent system Inclusion Criteria - Infants: 1. Live-birth to mother enrolled in the study 2. Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable Exclusion Criteria: 1. Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, would substantially increase the risk associated with the maternal or infant participant's participation in and completion of the study 2. Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future newborn/infant in the study 3. High risk of prematurity as judged by treating clinician 4. Multiple pregnancy (i.e. twins, triplets or more) 5. Previous participation in the PIPELINE-RSV trial 6. Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial 7. Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine) 8. History of Guillain Barré Syndrome (GBS)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

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