Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns (NCT07251972) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns
France1,050 participantsStarted 2025-09-01
Plain-language summary
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed.
Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period.
Currently, no superiority or difference has been described for either immunoprophylaxis method.
Who can participate
Age range
4 Days – 8 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* all term born neonates
Exclusion Criteria:
* postnatal transfert
* born at home or in birthing center
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two methods of RSV immunoprophylaxis in term newborns — can you explain what those two methods are, and how they differ from what's currently recommended for my baby?
2Since this trial is no longer actively recruiting, does that mean my newborn can't participate, and are there other similar studies or options we should be looking into instead?
3The main thing this trial is measuring is whether bronchiolitis actually occurs — what does that tell us about how much is still unknown regarding how well these approaches prevent RSV-related illness in healthy term babies?
4This trial is listed as 'Phase NA,' which I understand can apply to studies that aren't testing a new drug — can you help me understand what that means for what's already known about the safety of these two immunoprophylaxis methods?
5Given that bronchiolitis can range from mild to serious, how would you weigh the potential benefit of joining a study like this against simply following the current standard RSV prevention approach for my newborn?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.