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PIPELINE-RSV-France
EU CTIS ID: 2025-521755-23-00
What this study is testing
To determine, in the French context, if the administration of maternal RSV vaccine Abrysvo (administered all year round between 32 and 36 weeks’ gestation + 6 days) PLUS nirsevimab (administered all year round at 4 months (+/- 1 month) is more efficacious (superiority testing) than seasonal nirsevimab (given to infants entering their first RSV season, i.e at birth for children born during the season or at the beginning of the epidemic for other infants) in preventing symptomatic RSV infections in infants during the first year of life.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pregnant women
- Affiliated to social security regime or an equivalent system
- Live-birth to mother enrolled in the study
- Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable
- Provide informed consent prior to study enrolment
- Willing and able (in the site investigator’s opinion) to comply with all study requirements
You likely can't join if
- 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
- 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
- High risk of prematurity as judged by treating clinician
- Multiple pregnancy (i.e. twins, triplets or more).
- Previous participation in the PIPELINE-RSV trial
- Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial
See the full eligibility criteria
- Pregnant women
- Affiliated to social security regime or an equivalent system
- Live-birth to mother enrolled in the study
- Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable
- Provide informed consent prior to study enrolment
- Willing and able (in the site investigator’s opinion) to comply with all study requirements
- More than 18 years of age
- Between 32 and 36 weeks + 6 days of gestation
- Able to read and complete the eHealth questionnaire in French or English
- Willing to receive maternal vaccine in pregnancy, if allocated
- Willing for the baby to receive infant nirsevimab
- Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial
- 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
- 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
- High risk of prematurity as judged by treating clinician
- Multiple pregnancy (i.e. twins, triplets or more).
- Previous participation in the PIPELINE-RSV trial
- Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial
- 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)
- History of Guillain Barré Syndrome (GBS)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.