The vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup C.
Conditions
Interventions
Trade Name: NeisVac-C
Product Name: NeisVac-C
Product Code: NeisVac-C
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NeisVac-C
CAS Number: 0
Current Sponsor code: unknown
Other des
Sponsors
National Institute of Public Health and Environment (RIVM, the Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy children aged 10, 13 or 15 years Vaccinated according to the Dutch National Immunization Programme (NIP) Vaccinated (primed) with Meningococcal C conjugated vaccine one time at a young age Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Severe acute (infectious) illness of fever (>38.5°C) within 14 days before vaccination; - Antibiotic use within 14 days of enrollment; - Present evidence of serious disease(s) demanding medical treatment that might interfere the results of the study (chronic infection, bleeding disorder, immune dysfunction, genetic anomaly); - Known or suspected allergy to any of the vaccine components (by medical history); - Occurrence of (serious) adverse event after primary MenCC vaccination or other vaccination (by medical history) - Known or suspected immune deficiency; - History of any neurologic disorder, including epilepsy; - Previous administration of plasma products (including immunoglobulins) within the last 6 months; - Pregnancy. - Previous confirmed or suspected meningococcal disease. - Former received doses of MenC vaccines in addition to the primary vaccination - Received Hepatitis B vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess serum MenC-PS specific IgG levels at T0 (prior to vaccination) and at 1 month (T1) and 1 year (T2) after the second MenCC vaccination and determine whether there is a difference in IgG levels between the different age groups (persistence of vaccine induced antibody levels) - To assess serum bactericidal antibody assay (SBA) levels at T0 and at 1 month (T1) and 1 year (T2) after the second MenCC vaccination and determine whether there is a difference between the different age groups in the levels and the proportion of participants that have an SBA level of =8 (persistence of vaccine induced protective antibody levels). - To assess avidity of serum IgG antibodies and determine whether there is a difference in avidity between the different age groups ;Secondary Objective: - To determine whether there is a difference in antibody subclasses (e.g. IgG1-4, IgG1/IgG2 ratio) between the different age groups. - To determine whether there is a difference in avidity of IgG antibodies after primary versus secondary vaccination. - To investigate longitudinal kinetics of B- and T- cell memory immune responses after primary and secondary MenCC vaccination - To measure serum IgG antibody levels against tetanus, the carrier protein for the MenC polysaccharide in the conjugate vaccine, to investigate the effect of a second MenCC vaccine on these titers. - To measure salivary and serum IgA levels at T0, T1 and T2 in order to investigate their correlation and the (longitudinal) kinetics of local and systemic IgA production after primary and secondary MenCC vaccination. IgA is the major antibody at mucosal surfaces and considered to be important in limiting meningococcal colonisation and preventing early invasion. ;Primary end point(s): Differences between the three age groups (10, 13 and 15 years) in serum MenC-PS specific IgG antibodies and SBA levels 1 month and 1 year after the (second) MenCC vaccination. | — |
Countries
Netherlands
Outcome results
None listed