Infant WheezeINSPIRATIONNCT07317141
The Effectiveness of Early Immunisation With Nirsevimab on Preschool Wheezing in France, Based on an Analysis of Data From the French Health System Database.
An observational study of Infant Wheeze and Preschool Age Children, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant Wheeze, Preschool Age Children, Asthma Childhood
- What is being tested?
- Effectiveness of passive immunization with nirsevimab
- Type of treatment
- Vaccines
- How many people
- 218,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: The study cohorts will combine individual data from the National Health Data System (SNDS), covering the entire French population, and hospitalization data from the French Medicalization of Information Systems Program (PMSI). The SNDS includes socio-demographic data, outpatient reimbursements (including prescriptions), and inpatient care with diagnoses and procedures. The PMSI provides details on hospital stays, diagnoses, and procedures. All data are linked via unique anonymous identifiers. With an average of 60,000 births per month and a 20% exclusion rate, investigators estimate 576,000 eligible patients, exceeding the required sample size (218,000: 70,000 exposed, 148,000 non-exposed).
Who may be able to join
- - Exposed group of children: all children born between 06/02/2023 and 31/01/2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied.
- Unexposed group of children: all children born between 06/02/2023 and 31/01/2024 and who did not receive nirsevimab
Who cannot join
- - Infants born in Overseas Departments and Territories (Guadeloupe, Martinique, Guyana, La Réunion, Mayotte, Saint-Pierre-et-Miquelon, French Polynesia, Nouvelle-Calédonie, Wallis-et-Futuna, French Southern and Antarctic Lands, Clipperton island)
- Same-sex twins, as they cannot be differentiated in the French Medicalization of Information Systems Program (PMSI)
- Infants born between 06/02/2023 and 31/01/2024 in a maternity unit that has not reported data on the immunization with nirsevimab
- Infants whose mother had been vaccinated against RSV during pregnancy
- Infants who received palivizumab immunization
- Date of nirsevimab immunization not provided
Show all 9Show fewer
- Infants hospitalized for wheezing or RSV+ lower respiratory tract infection before receiving nirsevimab
- Infants who were immunized after 12 months of age for outcomes collected between 2 and 6 years old
- Infants who were immunized after 6 months of age for outcomes collected during the second year of life
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
OULDALI N REIX, N, contact
About this study
Official title: Effectiveness of Early Immunization With Nirsevimab on Preschool Wheezing in France
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.
Read more
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
- Being tested
- Effectiveness of passive immunization with nirsevimab
- Keywords
- nirsevimab, wheezing disease, infants, preschoolers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of passive immunization with nirsevimabOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Exposed group of children: all children born between 06/02/2023 and 31/01/2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied. Receives: Other: Effectiveness of passive immunization with nirsevimab | |
| Non-exposed | Unexposed group of children: all children born between June 06/02/2023 and 31/01/2024 and who did not received nirsevimab. The following matching features will be used to ensure comparability between the two groups: sex, month of birth, department of birth. Immunized and non-immunized infants will be matched at a 1:2 ratio. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for wheezing episodes among infants immunized with nirsevimab (exposed group) vs non-immunized (non-exposed group)
The investigators will compare rates of hospitalization between the two groups. Our primary outcome will be captured by using the asthma-related ICD10 codes J45, J46; bronchiolitis related ICD-10 code J21, respiratory failure J96 and wheezing associated respiratory ill
Measured: During the second year of life (exactly between 6 and 24 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant WheezeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 218,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317141
- Sponsor's protocol ID
- 69HCL25_0734
- Acronym
- INSPIRATION
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Immunization With Nirsevimab on Preschool Wheezing in France
- ClinicalTrials.gov ID
- NCT07317141
- Acronym / sponsor ID
- INSPIRATION / 69HCL25_0734
- Conditions
- Infant Wheeze, Preschool Age Children, Asthma Childhood
- Keywords
- nirsevimab, wheezing disease, infants, preschoolers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 218,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: Effectiveness of passive immunization with nirsevimabExposed group of children: all children born between 06/02/2023 and 31/01/2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied. |
| Non-exposed | – | –Unexposed group of children: all children born between June 06/02/2023 and 31/01/2024 and who did not received nirsevimab. The following matching features will be used to ensure comparability between the two groups: sex, month of birth, department of birth. Immunized and non-immunized infants will be matched at a 1:2 ratio. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study cohorts will combine individual data from the National Health Data System (SNDS), covering the entire French population, and hospitalization data from the French Medicalization of Information Systems Program (PMSI). The SNDS includes socio-demographic data, outpatient reimbursements (including prescriptions), and inpatient care with diagnoses and procedures. The PMSI provides details on hospital stays, diagnoses, and procedures. All data are linked via unique anonymous identifiers. With an average of 60,000 births per month and a 20% exclusion rate, investigators estimate 576,000 eligible patients, exceeding the required sample size (218,000: 70,000 exposed, 148,000 non-exposed).
Key inclusion criteria (2 listed)
- - Exposed group of children: all children born between 06/02/2023 and 31/01/2024 and who had received nirsevimab before 6 or 12 months of age depending on the outcomes that will be studied.
- Unexposed group of children: all children born between 06/02/2023 and 31/01/2024 and who did not receive nirsevimab
Key exclusion criteria (9 listed)
- - Infants born in Overseas Departments and Territories (Guadeloupe, Martinique, Guyana, La Réunion, Mayotte, Saint-Pierre-et-Miquelon, French Polynesia, Nouvelle-Calédonie, Wallis-et-Futuna, French Southern and Antarctic Lands, Clipperton island)
- Same-sex twins, as they cannot be differentiated in the French Medicalization of Information Systems Program (PMSI)
- Infants born between 06/02/2023 and 31/01/2024 in a maternity unit that has not reported data on the immunization with nirsevimab
- Infants whose mother had been vaccinated against RSV during pregnancy
- Infants who received palivizumab immunization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of passive immunization with nirsevimabThe 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. | Other | Exposed |
Primary outcome
Hospitalization for wheezing episodes among infants immunized with nirsevimab (exposed group) vs non-immunized (non-exposed group)
Time frame: During the second year of life (exactly between 6 and 24 months of age)
The investigators will compare rates of hospitalization between the two groups. Our primary outcome will be captured by using the asthma-related ICD10 codes J45, J46; bronchiolitis related ICD-10 code J21, respiratory failure J96 and wheezing associated respiratory ill
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
OULDALI N REIX, N, contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Wheeze and Preschool Age Children, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact REIX P REIX, P, Pr, Pr (+33 4 27 85 54 70, philippe.reix@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for wheezing episodes among infants immunized with nirsevimab (exposed group) vs non-immunized (non-exposed group) (time frame: During the second year of life (exactly between 6 and 24 months of age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.