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Double defense against RSV: could Mom's vaccine plus Baby's shot be the key?
NCT ID NCT07232706
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHD Vendée
RECRUITINGLa Roche-sur-Yon, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Czech RSV shot study: will parents protect their babies?
- Queensland study reveals why parents say yes or no to RSV shot for babies
- New RSV vaccine for infants shows promise in major trial
- Can the RSV vaccine protect the most vulnerable? new study aims to find out
- One-dose antibody slashes RSV hospitalizations in infants