Clinical trial • Phase III • Respiratory
NIRSEVIMAB for Respiratory syncytial virus (RSV) infection
Phase III trial of NIRSEVIMAB for Respiratory syncytial virus (RSV) infection.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Respiratory syncytial virus (RSV) infection
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Vaccine
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 28-07-2025
- First CTIS Authorization Date
- 04-11-2025
Trial design
Randomised, open-label, arms: mv — maternal vaccine (abrysvo) administered between 24+0 and 36+6 weeks of gestation; seasonal mab — infant monoclonal antibody (nirsevimab, beyfortus) given to infants entering their first rsv season; mv and mab at 4 months — combination arm with maternal vaccine plus infant mab at 4 months. (timing/schedule provided; product strengths in dossier: beyfortus 50 mg and 100 mg im; abrysvo 0.5 ml im.)-controlled, adaptive Phase III trial in Belgium, Netherlands.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arms: MV — Maternal vaccine (Abrysvo) administered between 24+0 and 36+6 weeks of gestation; Seasonal mAb — infant monoclonal antibody (nirsevimab, Beyfortus) given to infants entering their first RSV season; MV and mAb at 4 months — combination arm with maternal vaccine plus infant mAb at 4 months. (Timing/schedule provided; product strengths in dossier: Beyfortus 50 mg and 100 mg IM; Abrysvo 0.5 ml IM.)
- Adaptive
- True, described as an adaptive platform trial comparing multiple interventions (adaptive platform design). Specific adaptive rules (e.g. interim analysis boundaries, stopping rules, or response-adaptive allocation details) are not provided in the available JSON.
- Target Sample Size
- 1100
Eligibility
Recruits 1100 paediatric patients.
- Pregnancy Exclusion
- Pregnant woman - Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman’s participation in and completion of the study.
- Vulnerable Population
- The trial includes pregnant women and infants (vulnerable populations). Informed consent must be provided by the pregnant woman (who must be above the national legal age of consent). For infants, informed consent is provided by the mother and by other infant legal representative (i.e. partner/co-parent) or legal guardian(s) if required by local regulations. Participant-facing information and consent materials are provided (multiple language versions available as per submitted documents).
Inclusion criteria
- {"criterion_text":"- Pregnant woman - Pregnant woman.\n- Infant - Live-birth to mother enrolled in the study.\n- Pregnant woman - Provide informed consent prior to study enrolment.\n- Pregnant woman - Willing and able (in the Site Investigator’s opinion) to comply with all study requirements.\n- Pregnant woman - Above the national legal age of consent.\n- Pregnant woman - Between 24+0 (or later as per national guidance) and 36+6 weeks gestation.\n- Pregnant woman - Able to read and complete the Participant Facing Surveys in a language in which it is available.\n- Pregnant woman - Willing to receive MV in pregnancy, if allocated.\n- Pregnant woman - Willing for the baby to receive infant mAb, if allocated.\n- Infant - Informed consent provided by the mother, and other infant legal representative (i.e. partner / co-parent) or legal guardian(s) if required by local regulations."}
Exclusion criteria
- {"criterion_text":"- Pregnant woman - Major illness of the maternal participant or condition of the foetus that in the opinion of the Site Investigator would substantially increase the risk associated with the woman’s participation in and completion of the study.\n- Pregnant woman - Any suspected or confirmed condition in the foetus that in the opinion of the Site Investigator would contraindicate participation of the infant in the study.\n- Pregnant woman - High risk of prematurity as judged by treating clinician.\n- Pregnant woman - Multiple pregnancy (i.e. twins, triplets or more)\n- Pregnant woman - Previous participation in the PIPELINE-RSV trial.\n- Pregnant woman - History of Guillain Barre Syndrome.\n- Pregnant woman - Receipt of any previous RSV prevention product in this pregnancy or currently participating in another interventional RSV prevention trial.\n- Pregnant woman - Any contraindication for receipt of intramuscular injection (bleeding diathesis or a condition associated with prolonged bleeding) or of vaccine (history of severe allergic reaction e.g., anaphylaxis) to any component of the vaccine).\n- Infant - Note: all live born infants to mothers participating in the study will be included (with consent as required), but infant mAb will not be given if contraindicated."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Symptomatic RSV respiratory tract infection (RTI) in an infant, confirmed by an approved positive RSV test, by 12 months of age.","definition_or_measurement_approach":"Confirmed by an approved positive RSV test in an infant by 12 months of age."}
Recruitment
- Registry Or Advocacy Recruitment
- True, RESVINET; conect4children-Stichting
- Digital Remote Recruitment
- True, participant-facing eHealth surveys and questionnaires are provided (multiple eHealth/participant-facing documents listed in EN, NL, FR indicating digital/remote participant-facing materials).
- Planned Sample Size
- 1100
- Recruitment Window Months
- 45
- Consent Approach
- Pregnant women provide informed consent prior to study enrolment and must be above the national legal age of consent. For infants, informed consent is provided by the mother and by other infant legal representative (partner/co-parent) or legal guardian(s) if required by local regulations. Subject information and informed consent forms and participant-facing questionnaires are available in multiple language versions (documents available in EN, NL, FR as submitted).
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 400
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Centre for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute
- Contact Person Name
- Paolo Palma
- Contact Person Email
- paolo.palma@uantwerpen.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 6
- Number Of Sites
- 2
- Number Of Participants
- 250
Sites
- Site Name
- Diakonessenhuis Stichting
- Department Name
- Gynaecology
- Contact Person Name
- Koen Deurloo
- Contact Person Email
- wetenschapsbureau@diakhuis.nl
- Site Name
- Wilhelmina Childrens Hospital
- Department Name
- Pediatrics
- Contact Person Name
- Joanne Wildenbeest
- Contact Person Email
- Clusterb@umcutrecht.nl
Sponsor
Primary sponsor
- Full Name
- Fondazione Penta Ets
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Italy
Third parties
- {"country":"Italy","full_name":"Universita' Degli Studi Di Roma Tor Vergata","duties_or_roles":"Immune Substudy; code 4","organisation_type":"Educational Institution"}
- {"country":"Belgium","full_name":"University Of Antwerp","duties_or_roles":"Social Science Studies","organisation_type":"Educational Institution"}
- {"country":"United Kingdom","full_name":"St Georges University Hospitals NHS Foundation Trust","duties_or_roles":"codes 11, 12, 13","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Institut National De La Sante Et De La Recherche Medicale","duties_or_roles":"code 8","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"conect4children-Stichting","duties_or_roles":"Through its paneuropean clinical trial network and selected National Hubs, will provide ad hoc support, facilitation and issue resolution to sponsor and sites at country and/or site level, during trial setup and execution (non-GxP activities)","organisation_type":"Health care"}
- {"country":"Spain","full_name":"Servicio Madrileno De Salud","duties_or_roles":"code 13","organisation_type":"Health care"}
- {"country":"Netherlands","full_name":"Universitair Medisch Centrum Utrecht","duties_or_roles":"codes 2, 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Universite Paris Cite","duties_or_roles":"codes 11, 13","organisation_type":"Educational Institution"}
- {"country":"United Kingdom","full_name":"University College London","duties_or_roles":"codes 10, 11","organisation_type":"Educational Institution"}
- {"country":"Italy","full_name":"Istituto Per L'Interscambio Scientifico Abbreviabile Fondazione I.S.I.","duties_or_roles":"code 6","organisation_type":"Health care"}
- {"country":"Netherlands","full_name":"Ecraid","duties_or_roles":"codes 1, 12, 5","organisation_type":"Health care"}
- {"country":"Netherlands","full_name":"RESVINET","duties_or_roles":"Patient and Public Involvement","organisation_type":"Patient organisation/association"}
- {"country":"France","full_name":"Centre Hospitalier Annecy Genevois","duties_or_roles":"code 10","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Vanderbilt University Medical Center","duties_or_roles":"code 7","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Beyfortus 100 mg solution for injection in pre-filled syringe
- Active Substance
- NIRSEVIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/22/1689/004)
- Starting Dose
- 100 mg
- Dose Levels
- 100 mg
- Frequency
- Single administration
- Maximum Dose
- 100 mg
- Investigational Product Name
- Beyfortus 50 mg solution for injection in pre-filled syringe
- Active Substance
- NIRSEVIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/22/1689/001)
- Starting Dose
- 50 mg
- Dose Levels
- 50 mg
- Frequency
- Single administration
- Maximum Dose
- 50 mg
- Investigational Product Name
- Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant)
- Active Substance
- RSV subgroup A stabilized prefusion F protein (847A) and RSV subgroup B stabilized prefusion F protein (847B)
- Modality
- Vaccine
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/23/1752/001)
- Starting Dose
- 0.5 ml
- Dose Levels
- 0.5 ml
- Frequency
- Single administration
- Maximum Dose
- 0.5 ml
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- NIRSEVIMAB for Respiratory syncytial virus (RSV) infection
- phospholipid fraction, bovine lung for Idiopathic pulmonary fibrosis
- Allogeneic bone marrow-derived mesenchymal adult stromal cells, ex-vivo expanded for Chronic lung allograft dysfunction (CLAD) | Bronchiolitis obliterans syndrome (BOS) in lung transplant recipients
- IVX-121; HUMAN METAPNEUMOVIRUS, VIRUS-LIKE PROTEIN for Respiratory syncytial virus infection | Human metapneumovirus infection
- Lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus (Diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella/Neisseria) catarrhalis (OM-85) for Respiratory tract infections with wheezing lower respiratory illness