E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infection by HPV 6, 11, 16, 18 |
Infection par les papillomavirus humains (HPV) 6, 11, 16, 18 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 persistence of immunological response to tetravalent HPV vaccine at 18 months after first dose of vaccine |
Évaluer la réponse immunologique au vaccin anti-HPV tétravalent 18 mois après le début de la vaccination. |
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E.2.2 | Secondary objectives of the trial |
- To study immunologic response at M7, M18, and M36 - To study anti-HPV T cell response at M7 and M18 - To describe frequency and distributions of HPV genotypes in the genital tractus - To evaluate the occurrence of clinical lesions (genital warts, cervical lesions) - To describe the frequency of adverse events
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- étudier la réponse immunologique à 7, 18, et 36 mois - décrire la réponse cellulaire T anti-HPV à M7 et M18 - décrire la fréquence et la distribution de l’infection génitale par HPV - évaluer la survenue de lésions cliniques (condylomes, lésions cervicales) - évaluer la tolérance de la vaccination de M0 à M36.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Female gender - Age ≥ 9 years - Solid organ transplantation: kidney, liver, heart, lung, intestinal or combined transplant; or systemic lupus erythematosus or other systemic immune disease - Transplantation or diagnosis of lupus since more than 6 months - Immunosuppressant treatment by anti-metabolites or calcineurin inhibitors, with or without associated corticosteroids - Minimum required period of 3 months considered as stable after transplantation or without relapse of lupus according to physician evaluation - In case of sexual activity (assessed by auto-declaration): onset less than one year before inclusion - Written informed consent signed by the investigator and the legal representatives of the patient, and assent by the patient
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- sexe féminin - âge supérieur ou égal à 9 ans - transplantation d’organe solide : rénale, hépatique, cardiaque, pulmonaire ou combinée ; ou lupus érythémateux disséminé ou autres maladie immune systémique - délai minimum de 6 mois après transplantation ou après diagnostic de lupus - traitement immunosuppresseur de type anti-métabolite ou anti-calcineurine avec ou sans corticothérapie associée - période minimale de stabilité : période de 3 mois considérée comme stable par le clinicien en post greffe ou sans poussée évolutive de la maladie selon l’évaluation du clinicien en cas de lupus - en cas d’activité sexuelle auto déclarée : début depuis moins d’un an - consentement libre, éclairé et écrit, signé par les deux représentants de l’autorité parentale, la patiente et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par l’étude)
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E.4 | Principal exclusion criteria |
- Male gender - Pregnancy - Age < 9 years or > 18 years - Previous HPV vaccination - Immunosuppressive treatment by anti-TNF (adalimumab, etanercept, infliximab) or monoclonal antibodies (rituximab, anakinra, abatacept) during the last 3 months - Active malignancy - Active opportunistic infection - HIV infection - Concurrent clinical trial
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- sexe masculin - âge inférieur à 9 ans ou supérieur à 18 ans - vaccination anti-HPV préalable - pathologie tumorale active - infection opportuniste active - infection par le VIH - grossesse en cours - traitement immunosuppresseur de type anti-TNF (adalimumab, etanercept, infliximab) ou anticorps monoclonal (rituximab, anakinra, abatacept…) datant de moins de 3 mois - participation à un autre essai clinique |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seroconversion rate for HPV 16 and 18 at M18 |
Proportion de séroconversion HPV dans les génotypes 16 et 18 à M18. La séroconversion sera définie en fonction d’un seuil de séropositivité des anticorps estimé à partir d’un seuil témoin de référence. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
18 month after first injection |
18 mois la première injection de vaccin |
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E.5.2 | Secondary end point(s) |
Geometric means of anti-HPV 16 and 18 antibody titers at M7, M18, and M36, respectively. Proportion of patients with a good cell response at M7 and M18 Number, type and time of occurrence of HPV genotypes 6, 11, 16, 18 in the genital tractus Proportion of patients with genital warts or cervical lesions (if relevant) Number, type and time of occurrence of adverse events of any grade between D0 and M36
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Les principaux critères de jugement secondaires sont les moyennes géométriques des titres d’anticorps anti-HPV 16 et 18 à M7, M18, et M36. Les autres critères de jugement secondaires sont : - la proportion de patientes avec une bonne réponse cellulaire T. - la fréquence et la distribution des génotypes 6, 11,16, 18 - la fréquence des lésions génitales externes ou, en cas d’activité sexuelle déclarée, cervicales - le nombre, la nature et le délai de survenue des effets indésirables (quel que soit leur grade) de J0 à M36
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 13 |
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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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 | 48 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 48 |