E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Meningococcal Group C Disease |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the immunological responses of children over time when vaccinated with MCC-TT up to ten years after completion of vaccination with MCC-TT at 2, 3 and 4 months of age and further MCC or MACP vaccination in the second year of life:
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E.2.2 | Secondary objectives of the trial |
To measure the pre- to post-vaccination mean fold rise in SBA titre and the proportion of subjects with 4 fold rises between these samples.
To assess avidity indices of meningococccal group C
To assess the cell mediated immune responses
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
No contraindications to vaccination as specified in the “Green Book” – Immunisation Against Infectious Disease, HMSO.
Written informed consent obtained from the child and their parent or legal guardian
Child originally enrolled in the primary immunisation study and completed the booster phase in the second year of life
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E.4 | Principal exclusion criteria |
Current (to be checked prior to each vaccination):
Generalised acute systemic illness on the day of immunisation
Oral temperature >38oC on the day of immunisation
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E.5 End points |
E.5.1 | Primary end point(s) |
Blood will be tested for responses to the following, in order of priority:
1. Meningococcal serogroup C serum bactericidal antibody titres and IgG concentration 2. Meningococcal serogroup C avidity indices 3. Peripheral blood mononuclear cells (PBMC’s) will be isolated from fresh blood taken into heparinised tubes in order to permit the assessment of memory B cells by flow cytometry
Safety data will be collected by subjects using a 7 day health diary
1) local reactions (redness, swelling, tenderness) 2) daily temperature. 3) systemic symptoms. 4) visits to a doctor – hospital or GP
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.2 | Open | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | Information not present in EudraCT |
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 will be 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 | 2 |
E.8.9.1 | In the Member State concerned days | |