N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID; NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN; NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN; NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN for Invasive meningococcal disease | Sepsis | Meningitis

Inclusion criteria

• {"criterion_text":"- Participants eligible for this study are Dutch older persons 65-85 years of age"}
• {"criterion_text":"- Moderate to good general health with regard to age"}
• {"criterion_text":"- Did not receive a MenACWY-TT vaccine before"}

Exclusion criteria

• {"criterion_text":"- Antibiotic use within 14 days of enrolment"}
• {"criterion_text":"- Serious surgery within the last 3 months"}
• {"criterion_text":"- Previous vaccination with the MenC, MenC-TT or MenACWY-TT vaccine"}
• {"criterion_text":"- Previous confirmed or suspected meningococcal disease"}
• {"criterion_text":"- Any vaccination within a month before enrolment"}
• {"criterion_text":"- Known or suspected allergy to any of the vaccine components (by medical history)"}
• {"criterion_text":"- Severe acute infectious illness or fever above 38.0 °C within 14 days before vaccination"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Occurrence of a serious adverse event after other vaccination by medical history"}
• {"criterion_text":"- Known or suspected immune deficiency"}
• {"criterion_text":"- Known or suspected coagulation disorder"}
• {"criterion_text":"- Oral hormone use, such as postmenopausal hormones, within the last 3 months"}
• {"criterion_text":"- History of one of the following neurological disorders: multiple sclerosis, Parkinson’s disease, or epilepsy"}
• {"criterion_text":"- Previous administration of plasma-serum products including immunoglobulins within 6 months before vaccination and blood sampling"}

Primary endpoints

• {"endpoint_text":"- Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay.","definition_or_measurement_approach":"Measured using the serum bactericidal antibody (SBA) assay to determine functional antibody levels against MenA, MenC, MenW and MenY."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Comparison of SBA levels; threshold of ≥8 used to indicate persistence of protective antibody levels at 1 month and 1 year, and after booster."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement of MenA-PS, MenC-PS, MenW-PS and MenY-PS specific IgG levels in serum at 1 month and 1 year (and after booster) and comparison between age groups."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement of serum IgG levels against tetanus at 1 month and 1 year and comparison between groups and after booster."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement of serum IgA and IgM specific to MenA, MenC, MenW and MenY at specified timepoints and group comparisons."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment of MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month and 1 year with comparisons."}
• {"endpoint_text":"- To determine long-term persistence of functional serum antibody (IgG, IgA and IgM) titers (GMTs)/levels (GMCs) 5 years after primary vaccination","definition_or_measurement_approach":"Measurement of GMTs/GMCs of functional serum antibodies (IgG, IgA, IgM) at 5 years post-primary vaccination."}
• {"endpoint_text":"- To determine salivary MenA-PS, MenC-PS, MenW-PS and MenY-PS-specific IgG, IgA and IgM levels after primary and booster vaccination.","definition_or_measurement_approach":"Measurement of salivary IgG, IgA and IgM specific to MenA-PS, MenC-PS, MenW-PS and MenY-PS after primary and booster vaccination."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Comparative analysis of serum antibody levels and SBA titers against results from the StimulAge study."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Comparative analysis of salivary antibody levels with results from the StimulAge study."}

Netherlands

Earliest CTIS Part Ii Submission Date

07-05-2024

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

538

Number Of Sites

1

Number Of Participants

280

Primary sponsor

Full Name

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands