Preventing RSV in infants born in France during the 2024–2025 season
Official title: Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants: Maternal Vaccination During Pregnancy or Direct Immunization of Children? A French Online Study
Run by Assistance Publique - Hôpitaux de Paris · NCT06881953 · Data updated 2026-11-12
This questionnaire will see if infants born in metropolitan France between October 1, 2024 and January 31, 2025 are reached by and receive new RSV prevention measures such as nirsevimab or vaccines.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | palivizumab, nirsevimab |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | December 17, 2025 |
| Study ends | December 17, 2025 |
| Registry record updated | June 24, 2025 |
| Trial ID | NCT06881953 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are French-speaking women aged 18 or older who give birth to a live, term infant in metropolitan France between October 1, 2024 and January 31, 2025 and do not object to participation.
✕Probably not a fit
Women under legal protection, those who give birth before 37 weeks or outside the enrollment dates, or those unable to read French are unlikely to be included or to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use a questionnaire of mothers who deliver term infants in metropolitan France between October 1, 2024 and January 31, 2025 to document which RSV prevention measures their newborns receive and to identify barriers to uptake. Participants must be at least 18 years old, able to read and understand French, have a live term newborn, and not be under legal protection. The observational design collects self-reported data at participating sites including Hôpital Pitié Salpêtrière and public health departments without introducing any interventions. Results will describe national coverage of newer pharmacological options (for example nirsevimab and forthcoming vaccines) alongside existing non-pharmacological measures.
Why it matters
Potential benefit: If successful, the results could help public health teams improve outreach and increase newborn protection against RSV, potentially reducing infant hospitalizations.
How similar studies have gone: Randomized trials have shown that nirsevimab and maternal RSV vaccines can reduce severe RSV in infants, and prior observational surveillance has monitored uptake, but large-scale national coverage data for France in the 2024–25 season remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Able to speak and understand French well enough to read and comprehend the information leaflet and the questionnaire * Delivery in metropolitan France between October 1, 2024, and January 31, 2025 * Live-born child * Term-born child (37 weeks of gestation or more) * No objection to participating in the study Exclusion Criteria: * Women under legal protection
Where it's running
-
Public health department, Hôpital Pitié Salpêtrière
Paris, France Recruiting
Study contacts
- Study coordinator: Bénédicte COULM, RM,PhD
- Email: benedicte.coulm@aphp.fr
- Phone: 01 84 82 85 34
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Zelicapavir for RSV infection in young children
This study tests whether Zelicapavir can help treat RSV infection in children aged 28 days to 36 months who are showing symptoms.
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Revaccination with RSV vaccine during subsequent pregnancies
This study is testing if giving a second dose of the RSV vaccine to pregnant women who already had it is safe and effective for them and their babies.
-
Revaccination with SCB-1019T vaccine in older adults
This study is testing a new vaccine called SCB-1019T to see if it can boost immunity in healthy adults aged 60-85 who have already received the AREXVY vaccine.
-
Vaccination against RSV in patients with weakened immune systems
This study tests if giving two doses of the RSV vaccine to patients with weakened immune systems helps them better fight off RSV infections compared to the standard one dose given to healthy older adults.
-
Evaluating the effectiveness of RSV vaccines in real-world settings
This study is testing how well RSV vaccines work in the real world for infants who get respiratory illnesses.
-
Measuring how RSV affects young children seen in clinics and hospitals
This project will test adding lab tests for RSV, flu, and COVID-19 for children under 2 who come to clinics or hospitals with ear infections or bronchiolitis to see how often RSV causes their illness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.