Preventing RSV in Babies: Nirsevimab with or without maternal RSV vaccine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial examines the combination of maternal RSV vaccination during pregnancy and infant nirsevimab at birth to see if together they reduce RSV illness in newborns. Pregnant women between 32 and 36 weeks gestation are enrolled and may receive maternal vaccination, while their infants may also receive nirsevimab after birth. The study compares outcomes across groups to determine if dual protection provides added benefit over single preventive strategies. Safety monitoring and data sharing with related international efforts are included as part of the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pregnant women
2. Provide informed consent prior to study enrolment
3. Willing and able (in the site investigator's opinion) to comply with all study requirements
4. More than 18 years of age
5. Between 32 and 36 weeks of gestation
6. Able to read and complete the eHealth questionnaire in French or English
7. Willing to receive maternal vaccine in pregnancy, if allocated
8. Willing for the baby to receive infant nirsevimab
9. Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial
10. Affiliated to social security regime or an equivalent system

Inclusion Criteria - Infants:

1. Live-birth to mother enrolled in the study
2. Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable

Exclusion Criteria:

1. Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, would substantially increase the risk associated with the maternal or infant participant's participation in and completion of the study
2. Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future newborn/infant in the study
3. High risk of prematurity as judged by treating clinician
4. Multiple pregnancy (i.e. twins, triplets or more)
5. Previous participation in the PIPELINE-RSV trial
6. Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial
7. 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)
8. History of Guillain Barré Syndrome (GBS)

Where it's running

• CHD Vendée
  La Roche-sur-Yon, France Recruiting

Study contacts

• Principal investigator: Pierre Frange — Université Paris Cité
• Study coordinator: Marion Ghidi
• Email: mghidi@ch-annecygenevois.fr
• Phone: +33450637031

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Community programs to increase RSV vaccination among Latino adults

  This project tests whether community health worker counseling combined with text-message reminders can get more Latino older adults vaccinated against RSV and whether asking younger Latino adults to talk with older friends and family increases those conversations about RSV vaccination.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07171164

• Evaluating Nirsevimab's effect on RSV hospitalizations in infants

  This study is testing if a new antibody called Nirsevimab can help prevent infants under one year old from being hospitalized due to RSV infections.

  Recruiting at 8 sites Meyer Children's Hospital IRCCS · Arezzo, Arezzo and 7 other locations · NCT06856967

• Understanding viral infections in infants with bronchiolitis after Nirsevimab use

  This study looks at how the use of Nirsevimab affects the types of viral infections in infants under one year old who have their first episode of bronchiolitis.

  Recruiting University Hospital, Rouen · Rouen · NCT06636955

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.