MedTrace Logo

The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database.

NCT07317141 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 218000

Last updated 2026-01-08

No results posted yet for this study

Summary

Early respiratory syncytial virus (RSV) bronchiolitis is a well-known contributing factor of mid- and long-term respiratory sequelae in children such as recurrent lower tract respiratory infections (LRTIs), preschool wheezing (PW) or decreased lung function at older ages.

Nirsevimab, a monoclonal antibody against RSV with enhanced neutralizing activity and a prolonged half-life, has shown great potential in reducing short term outcomes such as hospitalization for RSV associated bronchiolitis (estimated adjusted effectiveness against hospitalization to 83.0% (95%CI: 73.4 to 89.2). Other countries that have been using nirsevimab almost exhaustively have reported similar results such as in Galicia.

However, prevention of RSV LRTI or delay RSV infection early in life has not been investigated on respiratory manifestations such early wheezing in infancy (ie before 2 years of age) and recurrent wheezing in preschool period (ie between 2 and 6 years old).

Some recent data have shown that nirsevimab was associated with a reduction of wheezing in the year following its administration (HR: 0.73; 95% CI, 0.58-0.93). Other data have shown that not being infected by RSV during the infancy was associated with 26% lower risk of 5-year current asthma than being infected (5) giving good rational for preventive strategies against RSV to impact midterm respiratory outcomes such as PW and then asthma.

Ongoing observational cohort studies will help investigate the question of mid-term effects, but they will come with a high costs and risk of attrition. Administrative national health claims database could prove to be useful and complementary by studying these types of real world outcomes across lives of children that have been immunized by nirsevimab as shown recently.

Therefore, the investigators aim to study the impact of early nirsevimab administration on wheezing manifestations occurring in infancy and beyond during the preschool years.

Our primary objective is to see if nirsevimab administration during the first six months of life has an impact on hospitalization for wheezing episodes during the second year of life, based on the hypothesis that infants who had received nirsevimab have reduced hospitalization for wheezing during their second year of infancy.

Conditions

  • Infant Wheeze
  • Preschool Age Children
  • Asthma Childhood

Interventions

OTHER

Effectiveness of passive immunization with nirsevimab

The investigators will assess the effectiveness of passive immunization with nirsevimab on the occurrence of wheezing during the preschool period. Assessment will be separated in two period of time Infants immunized before 6 Months of age will be assessed for hospitalization for wheezing before 2 years of age Infants immunized before 12 months of age will be assessed for recurrent wheezing before 6 years of age. An interim analysis at 4 years of age will be done.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-01
Completion
2029-06-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317141 on ClinicalTrials.gov