E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B |
Trabajadores del ámbito sanitario con riesgo biológico en sus tareas, que hayan sido vacunados como no-respondedores a la vacunación convencional contra la Hepatitis B |
|
E.1.1.1 | Medical condition in easily understood language |
Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B |
Trabajadores del ámbito sanitario con riesgo biológico en sus tareas, que hayan sido vacunados como no-respondedores a la vacunación convencional contra la Hepatitis B |
|
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 benefit and equip SACYL staff with an additional protection tool against hepatitis B infection.
To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine |
Beneficiar y dotar al personal de SACYL con una herramienta adicional de protección frente al contagio por hepatitis B.
Evaluar la eficacia de la vacuna adyuvada en aquellos sujetos sanos no-respondedores a la vacuna convencional antihepatitis B |
|
E.2.2 | Secondary objectives of the trial |
To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection.
To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine |
Beneficiar y dotar al personal de SACYL con una herramienta adicional de protección frente al contagio por hepatitis B.
Evaluar la eficacia de la vacuna adyuvada en aquellos sujetos sanos no-respondedores a la vacuna convencional antihepatitis B |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Health workers in the Health Area of Salamanca, Zamora, Leon, Valladolid and Palencia
Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers <10 mIU / ml following the application of six doses of conventional vaccine at 20 μg doses (two complete guidelines) |
Trabajadores del ámbito sanitario del Área de Salud de Salamanca, Zamora, Leon, Valladolid y Palencia
Criterios que les definen como NO respondedores a la vacuna convencional para hepatitis B: títulos de Ac antiHBs < 10 mUI/ml tras la aplicación de seis dosis de vacuna convencional a dosis de 20 μg (dos pautas completas)
Sujetos que firmen el consentimiento informado |
|
E.4 | Principal exclusion criteria |
Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet).
If you have ever had an allergic reaction to any vaccine against hepatitis B
If you have a serious infection with fever.
Subjects for whom informed consent is not obtained
Subjects that have not revoked the consent initially signed. |
Alergia conocida al principio activo o a cualquiera de los demás componentes del medicamento (incluidos en la sección 6 de la ficha técnica del producto).
Si ha tenido alguna vez una reacción alérgica a cualquier vacuna frente a la hepatitis B
Si tiene una infección grave con fiebre.
Sujetos de los cuales no se obtenga el consentimiento informado
Sujetos que no hayan revocado el consentimiento inicialmente firmado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SACYL health workers with biological risk in their tasks who have been classified as non-responders to vaccination against Hepatitis B |
Trabajadores del ámbito sanitario del SACYL, con riesgo biológico en sus tareas, que hayan sido clasificados como no-respondedores a la vacunación contra la Hepatitis B |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Between 40 and 60 days after the last dose given |
Entre los 40 y dos 60 días después de la ultima dosis administrada |
|
E.5.2 | Secondary end point(s) |
Analyze results of anti-HBs antibody titers to see the immune response to the adjuvanted vaccine.
To evaluate safety results and clinical tolerance of the adjuvanted vaccine |
Analizar resultados de títulos de anticuerpos antiHBs para ver la respuesta inmunológica a la vacuna adyuvada.
Evaluar resultados de seguridad y la tolerancia clínica de la vacuna adyuvada |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Al mes de la adminsitracion
En el momento de la administración de la vacuna y durante el mes posterior |
Al mes de la adminsitracion
En el momento de la administración de la vacuna y durante el mes posterior |
|
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 | 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) | 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 | 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 | 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
|
AT THE MONTH OF THE LAST VISIT OF THE LAST RECRUITED SUBJECT |
AL MES DE LA ULTIMA VISITA DEL ULTIMO SUJETO RECLUTADO |
|
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 | |
E.8.9.1 | In the Member State concerned days | |