Actively Recruiting

Age: 18Years +
FEMALE
ID06881953

Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants: Maternal Vaccination During Pregnancy or Direct Immunization of Children? A French Online Study

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-24

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Bronchiolitis is a viral infection affecting the lower respiratory tract, most often caused by the respiratory syncytial virus (RSV). It is a leading cause of infant hospitalizations for respiratory distress in Europe, with a significant impact on healthcare resources and families. This study focuses on understanding how pregnant women in France adhere to the current prevention strategies for RSV infections in infants, which have recently evolved with new options becoming available. The prevention strategies evaluated include maternal vaccination with the RSV vaccine Abrysvo during the third trimester of pregnancy and direct immunization of neonates with the monoclonal antibody nirsevimab. The maternal vaccine aims to transfer antibodies to the infant before birth, while nirsevimab is given as a single dose to neonates during their first RSV season. These strategies complement traditional non-pharmacological measures and are part of the national prevention program between September 2024 and January 2025. Participants in this observational study will complete an online questionnaire about 10 minutes long, which collects information about their choices regarding RSV prevention, factors influencing these choices, and reasons for adherence or non-adherence. The study will track adherence and related factors over six months, providing insights into maternal decision-making. The goal is to better understand how these prevention options are accepted and applied in the general population to inform future public health efforts.

CONDITIONS

Brief Title

Prevention Strategy for Respiratory Syncytial Virus (RSV) Infections in Infants in France

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able to speak and understand French well enough to read and comprehend the information leaflet and the questionnaire
  • Delivery planned in metropolitan France between October 1, 2024, and January 31, 2025
  • Expecting a live-born child
  • Child born at term (37 weeks of gestation or more)
  • No objection to participating in the study
Not Eligible

You will not qualify if you...

  • Women under legal protection

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 online screening and enrollment visit

Monitoring

Duration - Up to 6 months

Participants complete online questionnaires to report adherence to RSV prevention strategies and factors influencing their choices.

Periodic online questionnaires during the study period

Trial Site Locations

Total: 1 location

1

Public health department, Hôpital Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

B

Bénédicte COULM, RM,PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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