E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Our aim is to determine whether an additional dose of inactivated vaccine can increase the rate of responders among patients who have not responded adequately after 3 injections |
Notre but est ainsi de déterminer si une dose supplémentaire de vaccin inactivé peut permettre d’augmenter le taux de répondeurs parmi les patients ayant insuffisamment répondu après 3 injections. |
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E.1.1.1 | Medical condition in easily understood language |
Being a recipient of AG-CSH (Allograft of hematopoietic stem cells). |
Etre un receveur d'AG-CSH (Allogreffe de cellules souches hématopoïétiques).
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067859 |
E.1.2 | Term | Allogenic stem cell transplantation |
E.1.2 | System Organ Class | 100000004865 |
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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 |
In the case of an unsatisfactory response after 3 doses (M0-M1-M2), determine in the AG-CSH recipients whether an additional dose to M4 of diphtheria-tetanus-poliomyelitis-H.influenzae-HBV vaccine (Hexavalent vaccine also including pertussis valency) improves the M13 vaccine response (1 month after M12 vaccine booster). |
Déterminer chez les receveurs d’AG-CSH si, en cas de réponse non satisfaisante après 3 doses (M0-M1-M2), la réalisation d’une dose supplémentaire à M4 de vaccin diphtérie-tétanos-poliomyélite-H.influenzae-VHB (vaccin hexavalent comprenant également la valence coqueluche) permet d’améliorer la réponse vaccinale à M13 (1 mois après le rappel vaccinal à M12). |
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E.2.2 | Secondary objectives of the trial |
To determine the rate of responders against each of the 5 pathogens / infections 1 month after the 1 - year vaccine recall (at M13), by studying the impact of different patient - specific data (type of graft, type of conditioning, A GVH before vaccination ...) and the link between the response to M3 and that to M13. |
Déterminer le taux de patients répondeurs contre chacun des 5 pathogènes/infections 1 mois après le rappel vaccinal à 1 an (à M13), en étudiant l’impact de différentes données propres au patient (type de greffon, type de conditionnement, existence d’une GVH avant la vaccination …) et le lien entre la réponse à M3 et celle à M13. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age greater than or equal to 18 years - Realization of an allograft of haematopoietic stem cells at least 6 months, and at the most 24 months before inclusion - Discontinuation of immunosuppressive therapy for at least 3 months - Absence of GVH superior to grade I at the initiation of vaccination - Informed Consent |
- Age supérieur ou égal à 18 ans - Réalisation d’une allogreffe de cellules souches hématopoïétiques il y a au moins 6 mois, et au plus de 24 mois - Arrêt du traitement immunosuppresseur depuis au moins 3 mois - Absence de GVH supérieure au grade I lors de l’initiation de la vaccination - Consentement éclairé
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E.4 | Principal exclusion criteria |
- Pregnant, parturient or nursing women - Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, subject to administrative or judicial supervision - Patients who received supplementation in the last 3 months with multivalent immunoglobulins, or for whom this treatment is planned - Contra-indication to Infanrix hexa® (hypersensitivity during an earlier injection) - Fever (≥38 ° C) during consultation (delays inclusion at 1 week) |
- Femmes enceinte, parturiente, ou en cours d'allaitement - Personne privée de liberté par décision judiciaire ou administrative, personne faisant l’objet d’une mesure de protection légale, sujet sous surveillance administrative ou judiciaire - Patients ayant reçu dans les 3 mois précédents une supplémentation en immunoglobulines polyvalentes, ou pour qui ce traitement est prévu - Contre-indication à l’Infanrix hexa® (hypersensibilité lors d’une injection antérieure) - Fièvre (≥38°C) lors de la consultation (repousse l’inclusion à 1 semaine)
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E.5 End points |
E.5.1 | Primary end point(s) |
M13 vaccine response rate in patients with an unsatisfactory response at M3 (comparison between supplemented and non-supplemented groups and with the M3 responder group). The vaccine response will be characterized by the following criteria: - unsatisfactory response: protective antibodies against less than 4 infections / pathogens among diphtheria, tetanus, poliomyelitis, HBV, and H. influenzae b - satisfactory response: protective antibodies against at least 4 of these infections / pathogens |
Taux de réponse vaccinale à M13 chez les patients ayant une réponse non satisfaisante à M3 (comparaison entre les groupes ayant ou non reçu une dose supplémentaire ; et avec le groupe des répondeurs à M3). La réponse vaccinale sera caractérisée par les critères suivants : - réponse non satisfaisante : anticorps protecteurs contre moins de 4 infections/pathogènes parmi diphtérie, tétanos, poliomyélite, VHB, et H. influenzae b - réponse satisfaisante : anticorps protecteurs contre au moins 4 de ces infections/pathogènes
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Acquisition 1 month after vaccine recall at 1 year of a protective level of antibodies against the following pathogens / infections: diphtheria-tetanus-polyomyelitis- H.influenzae-HBV |
Acquisition 1 mois après le rappel vaccinal à 1 an d’un taux protecteur d’anticorps contre les pathogènes/infections suivantes : diphtérie-tétanos-polyomyélite- H.influenzae-VHB |
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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 | No |
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
la randomisation déterminera si le patient recevra une dose supplémentaire ou non de vaccin |
The randomization will determine if the patient will receive or not an additional dose of vaccine |
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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 | Yes |
E.8.2.3.1 | Comparator description |
pas de comparateur |
No comparator |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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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LVLS |
dernière visite du dernier sujet |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |