Invasive meningococcal disease, sepsis, meningitis
Conditions
Brief summary
Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay.
Detailed description
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)
Interventions
Sponsors
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional antibody levels against MenA, MenC, MenW and MenY are measured using the serum bactericidal antibody (SBA) assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 t | — |
Countries
Netherlands
Outcome results
None listed