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Prevention study for RSV Immunization
Official title Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
ClinicalTrials.gov ID: NCT07232706
What this study is testing
What is Nirsevimab?
Nirsevimab is an investigational medicine, given as a monthly injection into a muscle, being studied as a potential treatment for rsv immunization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women
- Provide informed consent prior to study enrolment
- Willing and able (in the site investigator's opinion) to comply with all study requirements
- More than 18 years of age
- Between 32 and 36 weeks of gestation
You likely can't join if
- Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, would substantially increase the risk...
- Any suspected or confirmed condition in the foetus that in the opinion of the site investigator would contraindicate participation of the future...
- High risk of prematurity as judged by treating clinician
- Multiple pregnancy (i.e. twins, triplets or more)
- Previous participation in the PIPELINE-RSV trial
- Receipt of any previous RSV prevention product in this pregnancy or currently participating in another treatment RSV prevention trial
See the full eligibility criteria
- Pregnant women
- Provide informed consent prior to study enrolment
- Willing and able (in the site investigator's opinion) to comply with all study requirements
- More than 18 years of age
- Between 32 and 36 weeks of gestation
- Able to read and complete the eHealth questionnaire in French or English
- Willing to receive maternal vaccine in pregnancy, if allocated
- Willing for the baby to receive infant nirsevimab
- Willing for their data to be re-used as part of the joint analysis with PIPELINE-RSV-International trial
- Affiliated to social security regime or an equivalent system
- Infants:
- Live-birth to mother enrolled in the study
- Informed consent from the mother, and the other legal representative (partner / co-parent) when applicable
- 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...
- 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
- High risk of prematurity as judged by treating clinician
- Multiple pregnancy (i.e. twins, triplets or more)
- Previous participation in the PIPELINE-RSV trial
- Receipt of any previous RSV prevention product in this pregnancy or currently participating in another treatment RSV prevention trial
- 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...
- History of Guillain Barré Syndrome (GBS)
The study team makes the final eligibility decision.
Where it's taking place
- La Roche-sur-Yon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Roche-sur-Yon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.