Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
280
Countries
1
Sites
1
Invasive meningococcal disease, sepsis, meningitis
Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay.
Key facts
- Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Participant type
- Healthy volunteers
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 13 May 2024 → ongoing
- Decision date (initial)
- 2024-05-13
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- RIVM
External identifiers
- EU CT number
- 2024-513640-29-00
- EudraCT number
- 2019-001301-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay.
Secondary objectives 9
- To compare SBA levels of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine long-term persistence of functional serum antibody (IgG, IgA and IgM) titers (GMTs)/levels (GMCs) 5 years after primary vaccination
- To determine salivary MenA-PS, MenC-PS, MenW-PS and MenY-PS-specific IgG, IgA and IgM levels after primary and booster vaccination.
- To compare the serum MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels and SBA titers from this study to the results found in the StimulAge study (NL48510.100.14)
- To compare the salivary MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels from this study to the results found in the StimulAge study (NL48510.100.14)
Conditions and MedDRA coding
Invasive meningococcal disease, sepsis, meningitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10076061 | Meningococcal immunisation | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants eligible for this study are Dutch older persons 65-85 years of age
- Moderate to good general health with regard to age
- Did not receive a MenACWY-TT vaccine before
Exclusion criteria 14
- Antibiotic use within 14 days of enrolment
- Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination
- Present evidence of serious diseases either demanding regular use of oral immunosuppressive medical treatment, like corticosteroids, that might interfere with the results of the study within the last 3 months or demanding acute use of high dose oral immunosuppressive that might interfere with the results of the study within the last 2 weeks
- Occurrence of a serious adverse event after other vaccination by medical history
- Known or suspected immune deficiency
- Known or suspected coagulation disorder
- Oral hormone use, such as postmenopausal hormones, within the last 3 months
- History of one of the following neurological disorders: multiple sclerosis, Parkinson’s disease, or epilepsy
- Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling
- Serious surgery within the last 3 months
- Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine
- Previous confirmed or suspected meningococcal disease
- Any vaccination within a month before enrolment
- Known or suspected allergy to any of the vaccine components (by medical history)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay.
Secondary endpoints 9
- To compare SBA levels of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month and 1 year within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month and 1 year and compare within the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine serum IgA and IgM levels against MenA, MenC, MenW and MenY at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year and compare between the two age groups and 1 month and 1 year after the booster vaccination in the booster-subcohort
- To determine long-term persistence of functional serum antibody (IgG, IgA and IgM) titers (GMTs)/levels (GMCs) 5 years after primary vaccination
- To determine salivary MenA-PS, MenC-PS, MenW-PS and MenY-PS-specific IgG, IgA and IgM levels after primary and booster vaccination.
- To compare the serum MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels and SBA titers from this study to the results found in the StimulAge study (NL48510.100.14)
- To compare the salivary MenA-Ps, MenC-PS, MenW-PS and MenY-PS specific IgG, IgA and IgM levels from this study to the results found in the StimulAge study (NL48510.100.14)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD6527232 · Product
- Active substance
- N. Meningitidis Group C (Strain C11) Polysaccharide (De-O-Acetylated) Conjugated to Tetanus Toxoid
- Substance synonyms
- MENINGOCOCCAL GROUP C CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), NEISSERIA MENINGITIDIS GROUP C POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07AH08 — -
- Marketing authorisation
- EU/1/12/767/003
- MA holder
- PFIZER EUROPE MA EEIG
- 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
- Gerco den Hartog
Public contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Gerco den Hartog
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 280 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
IIV, 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 | 2024-05-13 | 2024-05-13 | 2025-10-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513640-29-00 Redacted | 9 |
| Protocol (for publication) | D4_Patient Facing documents_Questionnaires | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements 2024-513640-29-00 | 1 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material_tekst folder | 5 |
| Recruitment arrangements (for publication) | K2_NL_Recruitment material_wervingsbrief | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Redacted | 7.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Nimenrix | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis MS NL 2024-513640-29-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-26 | Netherlands | Acceptable 2024-05-13
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-09 | Netherlands | Acceptable 2025-10-27
|
2025-10-27 |