Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
250
Countries
1
Sites
1
Healthy infants receiving an RSV immunization to prevent for serious diseases due to an RSV infection
Determine the effect of nirsevimab immunization on the development of the infant’s own humoral immune response (antibody levels) after an RSV infection
Key facts
- Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Participant type
- Pediatric, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- National Insitute for Public Health and the Enivornment (RIVM)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Determine the effect of nirsevimab immunization on the development of the infant’s own humoral immune response (antibody levels) after an RSV infection
Secondary objectives 5
- Identification of RSV-infected infants
- Determine the kinetics of the decline in RSV-specific serum antibodies after immunization with nirsevimab
- Investigate the effect of age or weight at immunization, maternal antibodies and RSV infection on the kinetics of the decline of RSV-specific serum antibodies
- Determine the effect of nirsevimab immunization on the development of the infant’s own functional humoral immune response after an RSV infection
- Determine the relative contribution of the maternal and monoclonal (nirsevimab) fraction of RSV-specific serum antibodies
Conditions and MedDRA coding
Healthy infants receiving an RSV immunization to prevent for serious diseases due to an RSV infection
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | nirsevimab immunization Controlled trial in which infants of 0-3 months of age immunized with nirsevimab will be followed up to 12 months after immunization. They will be compared to the control group of children of 12-15 months of age who have not received the RSV immunization.
|
Not Applicable | None | Nirsevimab group: infants 0-3 months of age who receive the nirsevimab immunization Control group: Infants of 12-15 months of age who did not receive the nirsevimab immunization |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Nirsevimab group: Infants and newborns born before or at the beginning of the RSV season and are 0-4 months of age by immunization
- Control group: Children around 12-15 months of age at the start of the RSV season (September/October)
- Nirsevimab group: Infants eligible for the nirsevimab immunization and the parents/ legal representatives decided that the infants will receive the nirsevimab immunization
- Children have to be healthy according to the same health criteria applied in the well baby clinic when a child is immunized, e.g. also infants with small increases in body temperature or a cold are seen as children with normal health
- The parents/ legal representatives accept participation of their (unborn) child in the study according to the described procedures
- Presence of a signed informed consent (the parents/legal representatives have given written informed consent after receiving oral and written information)
Exclusion criteria 10
- Nirsevimab group: Having received nirsevimab immunization before study entry
- Control group: Having received nirsevimab immunization
- Control group: Being hospitalized due to a confirmed RSV infection
- The biological mother received an RSV vaccination during pregnancy
- Nirsevimab group: Confirmed RSV infection before study entry
- Active or past immunosuppressive or immune modulating medication. However, for steroid treatment the exclusion criteria are: receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) steroid treatment; daily corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2 weeks before study entry or repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) within 2 weeks before study entry. The use of hydrocortisone as a substitution therapy in case a subject does not produce sufficient amounts is allowed.
- Known or suspected immunological disorder
- Known or suspected bleeding disorder
- Premature infants born before 37 weeks gestational age
- Known or suspected serious underlying medical condition that can interfere with the results of the study. Such as, but not limited to, certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease, seizure disorder or cancer.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- RSV-specific antibody levels at 12 months post-nirsevimab immunization in the nirsevimab group and the control group (at 12-15 months of age)
Secondary endpoints 5
- RSV-specific serum IgA levels pre- and 2, 4, 6, 12 months post-nirsevimab immunization and in the control group
- RSV-specific serum antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization
- RSV-specific serum antibody concentration pre- and 2, 4, 6 and 12 months postnirsevimab immunization / Questionnaire data such as age and weight of immunization
- RSV-specific antibody neutralization and Fc-functionality at 12 months post immunization in the nirsevimab group and the control group
- RSV-specific monoclonal and maternal antibody levels pre- and 2, 4, 6 and 12 months post-nirsevimab immunization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Beyfortus 50 mg solution for injection in pre-filled syringe
PRD11017616 · Product
- Active substance
- Nirsevimab
- Substance synonyms
- MEDI8897, Anti-respiratory syncytial virus human IgG1k monoclonal antibody
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BD08 — -
- Marketing authorisation
- EU/1/22/1689/001
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Beyfortus 100 mg solution for injection in pre-filled syringe
PRD11016418 · Product
- Active substance
- Nirsevimab
- Substance synonyms
- MEDI8897, Anti-respiratory syncytial virus human IgG1k monoclonal antibody
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BD08 — -
- Marketing authorisation
- EU/1/22/1689/004
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Sponsor organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Address
- Antonie Van Leeuwenhoeklaan 9
- City
- Bilthoven
- Postcode
- 3721 MA
- Country
- Netherlands
Scientific contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Info RIVM
Public contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Info RIVM
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 250 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
KIM, Antonie Van Leeuwenhoeklaan 9, 3721 MA, Bilthoven
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-08-27 | 2025-09-19 | 2026-02-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521801-42-00_Redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing document_Diary | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Questionaire control group | 2.0 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire nirsevimab group | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Aanmeldformulier IRIS-studie | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Begeleidende brief flyer controlegroep_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Begeleidende brief flyer Nirsevimab groep_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_opgemaakte wervingsflyer controlegroep_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_opgemaakte wervingsflyer Nirsevimab groep_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_tekst wervingsflyer controlegroep_Redacted | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_tekst wervingsflyer nirsevimab groep_Redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_websitetekst_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF control group_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF nirsevimab group_Redacted | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Beyfortus nirsevimab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2025-521801-42-00 | 3.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-29 | Netherlands | Acceptable 2025-07-16
|
2025-07-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-02 | Netherlands | Acceptable 2025-07-16
|
2025-10-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-14 | Netherlands | Acceptable 2025-11-05
|
2025-11-07 |