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Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)-RSV immunisation adaptive platform trial (PIPELINE-RSV)
EU CTIS ID: 2025-522194-11-00
What this study is testing
1. To determine if the administration of MV plus infant mAb at 4 months provides superior protection against symptomatic RSV infection in infants by 12 months of age compared with infant mAb given in the first RSV season after birth alone. 2. To determine if the administration of MV plus infant mAb at 4 months provides superior protection against symptomatic RSV infection in infants by 12 months of age compared with MV given alone.
- 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 woman - Pregnant woman.
- Infant - Live-birth to mother enrolled in the study.
- Pregnant woman - Provide informed consent prior to study enrolment.
- Pregnant woman - Willing and able (in the Site Investigator’s opinion) to comply with all study requirements.
- Pregnant woman - Above the national legal age of consent.
- Pregnant woman - Between 24+0 (or later as per national guidance) and 36+6 weeks gestation.
You likely can't join if
- Pregnant woman - Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman’s participation in and completion of the study.
- Pregnant woman - Any suspected or confirmed condition in the foetus that in the opinion of the Site Investigator would contraindicate participation of the infant in the study.
- Pregnant woman - High risk of prematurity as judged by treating clinician.
- Pregnant woman - Multiple pregnancy (i.e. twins, triplets or more)
- Pregnant woman - Previous participation in the PIPELINE-RSV trial.
- Pregnant woman - History of Guillain Barre Syndrome.
See the full eligibility criteria
- Pregnant woman - Pregnant woman.
- Infant - Live-birth to mother enrolled in the study.
- Pregnant woman - Provide informed consent prior to study enrolment.
- Pregnant woman - Willing and able (in the Site Investigator’s opinion) to comply with all study requirements.
- Pregnant woman - Above the national legal age of consent.
- Pregnant woman - Between 24+0 (or later as per national guidance) and 36+6 weeks gestation.
- Pregnant woman - Able to read and complete the Participant Facing Surveys in a language in which it is available.
- Pregnant woman - Willing to receive MV in pregnancy, if allocated.
- Pregnant woman - Willing for the baby to receive infant mAb, if allocated.
- Infant - Informed consent provided by the mother, and other infant legal representative (i.e. partner / co-parent) or legal guardian(s) if required by local regulations.
- Pregnant woman - Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman’s participation in and completion of the study.
- Pregnant woman - Any suspected or confirmed condition in the foetus that in the opinion of the Site Investigator would contraindicate participation of the infant in the study.
- Pregnant woman - High risk of prematurity as judged by treating clinician.
- Pregnant woman - Multiple pregnancy (i.e. twins, triplets or more)
- Pregnant woman - Previous participation in the PIPELINE-RSV trial.
- Pregnant woman - History of Guillain Barre Syndrome.
- Pregnant woman - Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial.
- Pregnant woman - 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).
- Infant - Note: all live born infants to mothers participating in the study will be included (with consent as required), but infant mAb will not be given if contraindicated.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United Kingdom
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, 0-17 years, in utero, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.