E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup C. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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
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E.2.2 | Secondary objectives of the trial |
- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |