E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The monovalent MenC-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal group C. The tetravelent MenACWY-TT vaccin administered in this study is used to prevent invasive disease caused by Meningococcal serogroup A, C, W and Y. |
Het monovalente MenC-TT vaccine beschermt tegen invasieve meningokokkenziekte van type C. Het tetravalente MenACWY-TT vaccine beschermt tegen invasieve meningokokkenziekte van type A, C, W en Y. |
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E.1.1.1 | Medical condition in easily understood language |
Invasive meningococcal disease - meningitis - sepsis |
Invasieve meningokokkenziekte - hersenvliesontsteking - bloedvergiftiging |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 |
The primary objective is to demonstrate non-inferiority of SBA levels against MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent MenACWY-TT vaccine as compared with the group vaccinated with monovalent MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.
If non-inferiority is demonstrated, the objective is to compare SBA levels against MenA, MenW and MenY at 1 year (T2) after vaccination between the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine. |
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E.2.2 | Secondary objectives of the trial |
See E.5.2 Secondary end points |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants are 10-, 12, and 15-year old children who have received a primary vaccination with a single dose of MenC-TT vaccine (NeisVac-C™) either during the mass catch-up campaign in 2002 (group 4 and 5) or at the age of 14 months (regular vaccination time point since 2002 according to the Dutch NIP; group 1,2 and 3).
Furthermore, participants have to fulfil all of the following criteria:
- Provision of written informed consent by both parents and (if child is 12 or 15 years old; see Annex 3) child;
- Good general health;
- Received all regular vaccines according to Dutch NIP;
- Adherent to protocol, and available during the study period. |
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E.4 | Principal exclusion criteria |
Any of the following criteria at the start of the study will exclude a volunteering child from participation:
- Severe acute (infectious) illness or fever (>38.5°C) within 14 days before vaccination;
- Antibiotic use within 14 days of enrollment;
- Present evidence of serious disease(s) demanding (immunosuppressive) medical treatment that might interfere the results of the study within the last 3 months (like, corticosteroids, 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 MenC-TT 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;
- Former received any tetravalent MenACWY vaccination;
- Received any vaccination in the past month. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to demonstrate non-inferiority of SBA levels against MenC at 1 year (T2) after vaccination in the group vaccinated with tetravalent MenACWY-TT vaccine as compared with the group vaccinated with monovalent MenC-TT conjugate vaccine in 10-, 12-, and 15-years old children.
If non-inferiority is demonstrated, the objective is to compare SBA levels against MenA, MenW and MenY at 1 year (T2) after vaccination between the three age groups that are vaccinated with tetravalent MenACWY-TT vaccine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
T0: First visit (Informed consent, blood sample, saliva sample and vaccination)
T1: Second visit 1 month after T0 (blood sample, saliva sample)
T2: Final visit 1 year after T0 (blood sample, saliva sample) |
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E.5.2 | Secondary end point(s) |
- To compare SBA levels against MenC at 1 month (T1) between the vaccine groups within the
three age groups.
- To compare SBA levels against MenC of ≥8 (persistence of vaccine induced protective antibody levels) at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups.
- To compare serum MenC-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the vaccine groups within the three age groups.
- To compare the decay rate of SBA levels and MenC-PS specific IgG levels after secondary vaccination (i.e. the difference between T2 and T1) between the vaccine groups within the three age groups.
- To compare SBA levels against MenA, MenW and MenY at 1 month (T1) between the three age groups within the MenACWY-TT vaccine group.
- To compare SBA levels against MenA, MenW and MenY of ≥8 at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group.
- To compare serum MenA-PS, MenY-PS and MenW-PS specific IgG levels at 1 month (T1) and 1 year (T2) between the three age groups within the MenACWY-TT vaccine group.
- To compare serum IgG antibody levels against tetanus, the carrier protein for both vaccines, at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups.
- To compare serum IgA levels against MenA, MenC, MenW and MenY at 1 month (T1) and at 1 year (T2) between the vaccine groups within the three age groups.
- To compare MenC-PS specific IgG subclasses (IgG1/IgG2 ratio) and avidity at 1 month (T1) and 1 year (T2)? between the vaccine groups within the three age groups.
- To compare SBA and IgG levels against MenC at 1 month and 1 year between the MenC-TT group of the current study and the TIM-study for the the 12- and 15- year olds, to establish the effect of the age at priming on antibody responses to a second MenC-TT vaccination during adolescence.
- Explorative: To measure saliva IgG and IgA levels at T0 1 month (T1) and 1 year (T2) in all groups.
- Explorative: To measure B- and T-cell memory immune responses at T0, 1 month (T1) and 1 year (T2) in all groups. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
T0: First visit (Informed consent, blood sample, saliva sample and vaccination)
T1: Second visit 1 month after T0 (blood sample, saliva sample)
T2: Final visit 1 year after T0 (blood sample, saliva sample) |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |