PIPELINE-RSV International Trial
Research type
Research Study
Full title
Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)- RSV immunisation adaptive platform trial
IRAS ID
1012051
Contact name
Giorgia Dalla Valle
Contact email
Sponsor organisation
Fondazione Penta ETS
Clinicaltrials.gov Identifier
Research summary
In recent years there have been outbreaks of new or re-emerging infections, such as Zika virus and COVID-19. Pregnant women and infants are at risk of serious health problems from some of these infections. Despite this, these populations are often excluded from research studies, meaning that is unclear whether new vaccines and treatments are safe and work well for them. The purpose of PIPELINE is to provide a European preparedness platform for clinical trials and observational studies to treat and prevent infections in pregnant women and infants. Studies conducted within the PIPELINE platform will allow dedicated studies in pregnant women and infants to happen more quickly, resulting in equal access to new medicines as they become available. The PIPELINE-RSV International Trial will test the platform by running a multi-country trial, focusing on preventing a common respiratory infection called RSV in infants. Currently two different medicines can be used to prevent RSV infection in babies: one is a vaccine given to the mother during pregnancy and the other is an injection given to the baby. It is not known whether giving one or the other, or both medicines together, would provide best protection. In the UK, the study will have two different groups: group 1 – a vaccine to the mother in pregnancy OR group 2 – both a vaccine to the mother in pregnancy and an injection to the baby at 4 months. Pregnant women aged 18 years or older, between 28+0 and 36+6 weeks’ gestational age, will be enrolled into the study, and followed up until the baby reaches 12 months of age. Visits with the mother and baby will occur at birth, 4 months, and 12 months, and a swab will be taken from the baby’s nose if they show possible signs of RSV infection.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
25/SC/0251
Date of REC Opinion
16 Sep 2025
REC opinion
Further Information Favourable Opinion