E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunogenic Study, in french children living in the region of Normandy, France, after vaccination for B:14:P1.7,16, to evaluate the longer-term persistence of antibodies against B:14P1.7,16. bacterial strain. |
étude d'immunogénicité menée chez des enfants de la zone de Neufchâtel-en Bray, afin de connaître la persistance à plus long terme des anticorps contre la souche B:14P1.7,16. |
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E.1.1.1 | Medical condition in easily understood language |
vaccination efficiency |
efficacité vaccinale |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10027203 |
E.1.2 | Term | Meningeal bacterial infections |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
Evaluation of French children living in the region of Normandy, France, after vaccination for B:14:P1.7,16, with hSBA level > 4, 2 years and 6 months after inoculation. |
L’objectif est de mesurer le pourcentage d'enfants présentant un titre hSBA ≥ 4 , 2ans et demi après le début de vaccination. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Enfants résidant en Seine-Maritime (dans les cantons de Neufchâtel en Bray et Forges les Eau) ou dans la Somme (zone ouest d'Abbeville), ayant participés à l'étude initiale intitulée "Evaluation de la réponse immunitaire contre la souche de Neisseria meningitidis B:14,P1.7,16 chez les sujets amenes a etre vaccines par menbvac" et appelés à l'administration d'une 4e dose par MenBVac®.
2) Consentement éclairé délivré par le(s) titulaire(s) de l’autorité parentale.
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E.4 | Principal exclusion criteria |
1) impossibilité d'obtenir le consentement du (des) titulaire(s) de l'autorité parentale,
2) impossibilité de réaliser les prélèvements sanguins avant la 1ère dose vaccinale,
3) impossibilité d'effectuer la 1ère dose vaccinale de MenBVac®
4) enfants sous curatelle ou tutelle
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E.5 End points |
E.5.1 | Primary end point(s) |
hsBA level |
titrage du hsBA |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
january 2013, March 2012 and january 2013 |
janvier 2012, Mars 2012 et janvier 2013 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | Yes |
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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 0 |
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
|
last visit of the last subject undergoing the trial |
dernière visite du dernier patient suivi dans le cadre de l'essai |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |