Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
250
Countries
1
Sites
1
Healthy volunteers
To evaluate and compare humoral, adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Key facts
- Sponsor
- Universiteit Gent
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2024-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- FWO (potentially) · Center for Vaccinology (CEVAC)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate and compare humoral, adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Secondary objectives 1
- To evaluate and compare the cellular (CD4+ and CD8+ T cell), adaptive immune responses elicited by two administrations of 4CMenB in transgender and cisgender healthy participants, aged 18 to 50 years.
Conditions and MedDRA coding
Healthy volunteers
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | This academic, prospective, interventional clinical study This academic, prospective, interventional clinical study is designed to evaluate the impact of gender and sex on immune responses by vaccinating healthy transgender and cisgender persons (18-50 years) IM with the 4CMenB (Bexsero®) vaccine
|
Not Applicable | None | Administration Arm: All participants will receive the same study intervention. Participants are grouped according to gender, not according to IMP administration. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1. Written signed informed consent form (ICF) obtained before any study-related activities.
- 2. Participants aged between, and including, 18 and 50 years of age at the time of signing the ICF which equals with the time of the first study intervention.
- 3. Participants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history andphysical examination at enrollment.
- 4. Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening.
- 5. POCBP (18-40 years of age) who are not pregnant or breastfeeding or planning to become pregnant during the clinical study.
- 6. Transgender persons need to be under stable gender-affirming hormone therapy (GAHT) for at least 6 months. Compliance needs to be documented by hormonal lab tests.
- 7. POCBP must have a negative urine pregnancy test at each vaccination visit (Visit 1 and Visit 5) Refer to Section 8.6.5 for Pregnancy Testing.
- 8. Participants who are willing and able to comply with the study procedures and are capable to comply with the requirements of the protocol (e.g. return for follow-up visits) as determined by the investigator.
Exclusion criteria 14
- 1. Current or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.
- 8. (former 10). History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
- 9. (former 11). Active malignancy or malignancy within the past 5 years that, in the opinion of the investigator, may affect immune response or participant safety - except for localized and fully treated cancers not requiring long-term therapy such as chemotherapy or radiotherapy (e.g. completely resected basal cell carcinoma, cervical intraepithelial neoplasia, melanoma in situ, early-stage thyroid cancer), based on the investigator’s clinical judgement.
- 10 (former 12). History of idiopathic urticaria within the past year.
- 11 (former 13). Currently pregnant, breast-feeding or planning to become pregnant. Cisgender women with permanent infertility due to an alternate medical cause (e.g. documented bilateral oophorectomy, androgen insensitivity, gonadal dysgenesis) are excluded to participate. For individuals with permanent infertility due to an alternate medical cause other than the above, investigator discretion should be applied to determining study entry. Additionally, cisgender women in a postmenopausal state, defined as no menses for 12 months without an alternative medical cause are also excluded to participate. Refer to Appendix 4 – Guidance on contraception and participants of childbearing potential.
- 12 (former 14). Any other clinical condition that, in the opinion of the investigator, could compromise the participant’s safety and/or compliance with the study protocol (e.g. current or recent (< 1 years ago) heavy smoking (> 20 cigarettes per day) or daily heavy vaping (equivalent to 20 cigarettes)41 , drug- or alcohol (> 15 units for cisgender men and transgender women or > 10 units or cisgender women and transgender men per week) abuse/addiction.
- 13 (former 15). Behavioral or cognitive impairment, unstable psychiatric conditions (e.g. forced admission, suicidal thoughts in the last two year) or other psychiatric disease that, in the opinion of the investigator, may interfere with study compliance, as well as with the subject’s ability and/or safety to participate in the study. Stable psychiatric conditions ( e.g. under-controlled depression) will be evaluated based on the investigators judgement.
- 14 (former 16). Donation of blood or blood products within 90 days prior to the first vaccination visit (Visit 1) until Day 56 (Visit 9).
- 2. Household contact with and/or intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life.
- 3. Transgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g. gonadotropin releasing hormone analogues).
- 4. Current or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.
- 5. Past or current confirmed or suspected immune-suppressive or immune-deficient condition, at the discretion of the investigator, including but not limited to blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders, lupus erythematosus and associated conditions or disorders (e.g. rheumatoid arthritis, scleroderma) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
- 6. History of confirmed hypersensitivity, anaphylaxis and/or other severe allergic reactions (e.g., generalized urticaria, angioedema, bronchospasm) to any component of the study vaccine or excipients (sodium chloride, histidine, sucrose, kanamycin and water for injection), medical products, or medical equipment whose use is foreseen in this study, as determined by the investigator.
- 7. Clinical conditions representing a contraindication for IM administration and blood draws, as judged by the investigator, e.g. thrombocytopenia or history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Quantification of human serum bactericidal antibody titers (hSBA) against reference strains for factor H binding protein (fHbp), Neisseria adhesin A (NadA) and Porine A (PorA) in serum collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), and 56 days post-primary vaccination with 4CMenB in transgender and cisgender participants.
- Comparison of hSBA antibody titers against reference strains for fHbp, NadA and PorA in serum samples collected at Day 0 and 28 (prior to primary and secondary vaccination, respectively), and 56 days post-primary vaccination with 4CMenB between transgender and cisgender participants.
Secondary endpoints 2
- Quantification of T cell-mediated immune responses in peripheral blood mononuclear cells (PBMCs) collected at Day 0 (prior to primary vaccination, baseline), and 56 days post-primary vaccination with 4CMenB in transgender and cisgender participants. The results will be expressed as frequencies of CD4+ or CD8+ T cells responding to 4CMenB antigen(s) and expressing two or more immune markers among CD40L, IFN-γ, IL-2, and TNF-α per million total CD4+ or CD8+ T cells as measured using intracellula
- Comparison of T cell-mediated immune responses in PBMCs collected at Day 0 (prior to primary vaccination, baseline), and 56 days post-primary vaccination with 4CMenB between transgender and cisgender participants. The results will be expressed as frequencies of CD4+ or CD8+ T cells responding to MenB antigens and expressing two or more immune markers among CD40L, IFN-γ, IL-2 and TNF-α per million total CD4+ or CD8+ T cells as measured using intracellular cytokine staining and flow cytometry (I
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
PRD2149125 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/002
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD769031 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/002
- MA holder
- GSK VACCINES S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149129 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/002
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149122 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149119 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/004
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149120 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/003
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149127 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/004
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149130 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149124 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/003
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149123 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/004
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149126 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149128 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/003
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149121 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/002
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD769032 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/003
- MA holder
- GSK VACCINES S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD769033 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/004
- MA holder
- GSK VACCINES S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD769030 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universiteit Gent
- Sponsor organisation
- Universiteit Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universiteit Gent
- Contact name
- Anthony Willems
Public contact point
- Organisation
- Universiteit Gent
- Contact name
- Anthony Willems
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 250 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2025-01-30 | 2025-02-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 36 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515599-11-00_for publication | 3.0 |
| Protocol (for publication) | D2_Patient facing__REDCap Manual for Participants_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing__REDCap Manual for Participants_NL_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Afspraak_V2-4_V6-10_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Afspraak_V2-4_V6-10_NL_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Afspraak_Vaccinatie_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Afspraak_Vaccinatie_NL_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_eDiary_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_eDiary_NL_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Reminder_dagboek_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Reminder_dagboek_NL_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_Subject Card_EN_for publication | 2.0 |
| Protocol (for publication) | D2_Patient facing_Subject Card_NL_for publication | 2.0 |
| Protocol (for publication) | D2_Patient facing_uitnodiging_dagboek_ENG_for publication | 1.0 |
| Protocol (for publication) | D2_Patient facing_uitnodiging_dagboek_NL_for publication | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_for publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Boodschap_website_for publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Intranet UZ mail_for pubilcation | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Social_Media_for publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Email_for publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_CG_for publication | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_TG_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF sponsor statement_for publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_EN_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_EN_Pregnancy_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_for publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_Pregnancy_for publication | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Letter EC Ghent approval prescreening procedure_for publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Mailboodschap pre-screening vragenlijst_for publication | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_PRE-SCREENING vragenlijst_for publication | 2.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_PRE-SCREENING_CEVAC_for publication | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC ENG Bexsero | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DU_2024-515599-11-00_for publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-515599-11-00_for publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-515599-11-00_for publication | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2024-515599-11-00_for publication | 3.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Belgium | Acceptable 2024-12-16
|
2024-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-07 | Belgium | Acceptable 2025-02-17
|
2025-02-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-03 | Belgium | Acceptable 2025-08-11
|
2025-08-11 |