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Study identifier: NCT07232706 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

Condition: RSV Immunization  ·  Sponsor: Centre Hospitalier Annecy Genevois

PhasePhase 3
Planned participants1000
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

RSV (which stands for Respiratory Syncytial Virus) is an infection that causes cold-like symptoms and is most common during winter months. Most people with RSV infection get better by themselves but babies and younger children can become very poorly. About 1 in 15 infants with confirmed RSV within the first 12 months of life will be hospitalised, and a very small proportion will be seriously ill and may die. Currently there are two different prevention options that can be used to prevent RSV infection in babies. One is a vaccine given to the mother during pregnancy, and the other is a monoclonal antibody given by injection to the baby. Although both prevention options work well on their own and are safe, neither provides 100% protection to the infant. It is not known whether giving both medicines, one to the mother in pregnancy and one to the infant, would provide better protection than giving only one medicine - this is what the PIPELINE-RSV study will look at. PIPELINE-RSV-France will recruit about 1000 pregnant women in France. A parallel trial, running across Europe (PIPELINE-RSV-International) will recruit about 1500 pregnant women in UK, Switzerland, the Netherlands and Belgium. The protocols will align on key aspects and the data will be analysed together. The study will include two study groups with different prevention options used in each: (1) an injection given to the baby at the beginning of RSV season, or (2) both a vaccine given to the mother in pregnancy and …

This description comes directly from the study's public registry record.

Talk to the study team

Marion Ghidi  ·  +33450637031  ·  mghidi@ch-annecygenevois.fr

Marie-Claire Parriault  ·  +33456497504  ·  mcparriault@ch-annecygenevois.fr

Always discuss trial participation with your own doctor first.

Locations (1)

CHD VendéeLa Roche-sur-Yon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07232706