NCT07232706: PIPELINE-RSV-F

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination: a Randomised Controlled Trial in France as Part of the Pregnancy and Infant PrEparedness pLatform IN Europe - PIPELINE

Recruiting now Phase 3 Last updated 22 May 2026

What this trial tests

Phase 3 trial testing Nirsevimab in RSV Immunization in 1,000 participants. Currently enrolling.

Timeline

6 May 2026

Primary endpoint
5 May 2029

5 May 2029

Quick facts

Lead sponsor	Centre Hospitalier Annecy Genevois
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,000
Start date	6 May 2026
Primary completion	5 May 2029
Estimated completion	5 May 2029
Sites	1 location across France

Drugs / interventions tested

• Nirsevimab (NIRSEVIMAB) — full drug profile →
• Abrysvo (abrysvo) — full drug profile →

Conditions studied

• RSV Immunization — all drugs for RSV Immunization →

Sponsor

Centre Hospitalier Annecy Genevois

Who can join

18 and older, any sex, with RSV Immunization. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Symptomatic RSV respiratory tract infection (RTI) in an infant, confirmed by an approved positive RSV test, by 12 months of age.
  Time frame: From birth to when the infant is 12 months of age.

Sponsor's own description

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 an injection given to the baby at around 4 months of age. Each mother-baby pair will be randomly allocated to group by a computer. The numbers of babies in each of these groups who acquire RSV will be compared. In some countries participating to the International trial, an other study groups may be available : (3) a vaccine given to the mother in pregnancy.

Pregnant women and their babies will be followed until the baby reaches 12 months of age. Information will be collected about medically-important side effects either the mother or the baby had from their medicine(s) and any symptoms of RSV the baby had. Visits with the mother and baby will occur at birth and 12 months later. The mother will complete questionnaires via a Web-based platform to report any non-routine in-person visits, once in pregnancy and after the baby is born twice a month or monthly (more often in the winter), to also report baby's symptoms, to report their trial experience when the baby is 4 and 12 months' old, and to provide their views on vaccination at birth, and when the baby is 4 and 12 months' old. If the baby develops symptoms that might be RSV, their mother or another caregiver will be asked to take a sample using a swab from the baby's nose or mouth, and to send it by post for testing to find out if the baby has RSV.

As well as the main research study, there are also some substudies. A questionnaire will be given to women who consent to take part, to find out their motivations for joining the study and how they prefer to receive information about taking part in studies. A small number of women will be asked to take part in a study to look at how mothers' and babies' immune systems respond to the two different study prevention options , and to investigate different ways of collecting samples from their babies. In addition, researchers will use data from the study to see whether giving both medicines is cost-effective compared with giving just one medicine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.