PIPELINE RSV
Pregnancy and Infant PrEparedness PLatform IN Europe (PIPELINE) RSV International Trial
What are the best ways to protect babies from Respiratory syncytial virus (RSV)? A phase 3 open labelled platform trial for RSV prevention in infants
What is this study about?
The PIPELINE-RSV trial will investigate two prevention options already licensed and in routine use in many countries. The trial will assess how well they protect infants from symptomatic Respiratory syncytial virus (RSV) during their first 12 months of life when used alone or in combination.
- Maternal RSV vaccination during pregnancy – A vaccine given to pregnant women that stimulates the production of antibodies against RSV. These antibodies pass to the baby through the placenta, helping to protect the infant during the first months of life.
- Monoclonal RSV antibody – A single dose given to infants before or in the beginning of their first RSV season. It provides immediate protection by delivering antibodies that help fight RSV.
The PIPELINE-RSV trial is sponsored by Fondazione Penta ETS (Penta) and it’s part of the PIPELINE project, an EU‑funded initiative that aims to improve pandemic preparedness by advancing the prevention and treatment of infections in pregnant women and infants.
Type of study
Randomised trial
Contact details
Data Sharing
See publication Policy: https://pipelineproject.eu/publication-policy/
Who is funding the study?
The Pregnancy and Infant PrEparedness PLatform IN Europe (PIPELINE) project (101155825) is funded by the European Union.
The PIPELINE Consortium is a collaboration of leading institutions specialising in maternal and infant health, infectious disease research, clinical trial design, and public health policy. It includes partners in Italy (Fondazione Penta ETS (Penta), Università degli Studi di Roma Tor Vergata (UNITOV), Istituto per l’Interscambio Scientifico (ISI), Università degli Studi di Verona (UNIVR)), France (Institut National de la Santé e de la Recherche Médicale (INSERM), Université Paris Cité (UPCité), Centre Hospitalier Annecy Genevois (CHAG), Ecole des Hautes Etudes en Santé Publique (EHESP)), The Netherlands (Universitair Medisch Centrum Utrecht (UMCU), Conect4children Stichting (c4c-S), Stichting European Clinical Research Alliance on Infectious Diseases (Ecraid), Stichting ReSViNET (ReSViNET)), UK (St George’s Hospital Medical School (SGUL), University College London (UCL)), Belgium (Universiteit Antwerpen (UANTWERPEN)),Spain (Servicio Madrileño de Salud (SERMAS)) and Croatia (Genos Glycoscience (Genos)).
When is it taking place?
Jan 2025 – Dec 2028 (48 months)
Where is it taking place?
Hospital sites across Europe, including the UK, Switzerland, Belgium and the Netherlands, with a parallel study in France called PIPELINE-RSV France.
Who is included?
Pregnant women, singleton pregnancy, between 24 and 36+6 weeks gestational age.