E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects undergoing voluntary vaccination |
Soggetti sani che stanno effettuando la vaccinazione volontariamente |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy subjects undergoing voluntary vaccination |
Soggetti sani che stanno effettuando la vaccinazione volontariamente |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule. |
Misurare la frequenza delle cellule B della memoria indotta dalla vaccinazione: verrà effettuato, pertanto, un prelievo al t0 prima della prima dose di vaccino e della seconda dose di vaccino e per verificarne poi la persistenza a 12, 24 e 36 mesi dal termine del ciclo vaccinale. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum
To correlate the level of serum antibodies to the frequency of specific memory B cells
|
Valutare l'influenza di ciascuna dose di vaccino sulla frequenza di cellule B di memoria e il livello di anticorpi specifici nel siero
Correlare il livello di anticorpi del siero e la frequenza di cellule B memoria specifiche |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a. Age 11 to 12 years old, at enrolment
Male and female
undergoing voluntary vaccination
Expected compliance form the subject and his/her parents to the study protocol
Signed Informed Consent Form (ICF) by parent(s) or legal representative(s) and by the subject
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soggetti di 11 e 12 anni di età, già compiuti all’arruolamento;
entrambi i sessi;
soggetti che sono volontariamente in procinto di effettuare la vaccinazione contro l’HPV
soggetti e loro genitori/tutore legale in grado di essere complianti con il protocollo di studio
ottenimento del consenso/assenso alla partecipazione da parte dei genitori/tutore legale e dei soggetti
|
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E.4 | Principal exclusion criteria |
Subjects suffering from hypersensitivity to human papillomavirus vaccine, yeast, or any component
Subjects under immunosuppressive treatment, suffering from hematological and neoplastic diseases
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Soggetti ipersensibili al vaccino , al lievito o ad altri componenti trattamento immunosoppressivo, malattie ematologiche e neoplastiche |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule. |
Misurare la frequenza delle cellule B della memoria indotta dalla vaccinazione: verrà effettuato, pertanto, un prelievo al t0 prima della prima dose di vaccino e della seconda dose di vaccino e per verificarne poi la persistenza a 12, 24 e 36 mesi dal termine del ciclo vaccinale. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum
To correlate the level of serum antibodies to the frequency of specific memory B cells
|
Valutare l'influenza di ciascuna dose di vaccino sulla frequenza di cellule B di memoria e il livello di anticorpi specifici nel siero
Correlare il livello di anticorpi del siero e la frequenza di cellule B memoria specifiche |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | 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 | 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.8.3 |
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 | 3 |
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
|
LVLS |
Ultima visita dell'ultimo paziente |
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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 | |