E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cervical cancer |
Cancer de cérvix |
|
E.1.1.1 | Medical condition in easily understood language |
Tumor in the cervix |
Tumor en el cérvix o cuello uterino |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056576 |
E.1.2 | Term | Cervical intraepithelial neoplasia |
E.1.2 | System Organ Class | 100000004872 |
|
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 |
The main aim of the study is: - To assess the uptake and identify the determinants of acceptability of HPV vaccination by women attending routinely screening visits. - To identify any logistic and programmatic issues such as (i) which information and how it is provided to women when offered the HPV vaccine, (ii) where is the vaccine stored, who should administer it and how should be adequately monitored and (iii) which is the best country-specific approach since women identification from screening visits until she is vaccinated.
The same objectives as above will be performed in a sub-study targeting under screened women in Spain. |
El objetivo principal del estudio es: - Estimar la aceptabilidad así como identificar los determinantes globales y locales de aceptabilidad de la vacunación frente a VPH por parte de mujeres que atienden de forma rutinaria a cribado de cuello uterino. - Identificar cualquier impedimento logístico y de programación, como pueden ser (i) qué información y cómo proporcionarla al ofrecer la vacuna de VPH, (ii) dónde se almacena la vacuna, quien debe administrarla y como se deben monitorizar adecuadamente los registros de la vacuna e (iii) identificar cual es el mejor procedimiento, por país, desde la identificación de mujeres elegibles mediante cribado hasta la administración de vacuna.
Estos mismos objetivos se realizaran en un sub-estudio, únicamente en España, en mujeres con una baja participación a cribado de cuello uterino. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study include: - Estimation of compliance with 1-, 2- and 3- doses of HPV vaccine - Monitoring of any adverse effects in the targeted population
The same objectives as above will be performed in a sub-study targeting under screened women in Spain. |
Los objetivos secundarios del estudio incluyen: - Estimar la adherencia a 1-, 2- y 3- dosis de vacuna frente a VPH - Monitorizar cualquier acontecimiento adverso en la población de estudio
Estos mismos objetivos se realizaran en un sub-estudio, únicamente en España, en mujeres con una baja participación a cribado de cuello uterino. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult women within the age range of 24-45 attending cervical cancer screening with no previous history of HPV vaccine administration. In Spain, also, women aged 35-40 yrs old with no screening record in the preceding 5 years |
Mujeres adultas entre 24-45 años que participan en programas de cribado de cáncer de cuello uterino y que no han recibido previamente la vacuna frente a VPH. En España, además, mujeres con edades entre 30 y 45 años que no se hayan realizado ninguna prueba de cribado en los 5 años anteriores |
|
E.4 | Principal exclusion criteria |
1. Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccines. 2. Known history of immune-related disorders 3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever. When recovered, the vaccine can be administered 4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose 5. Current pregnancy (reported), breast-feeding or planning to get pregnant in the coming 12 months. 6. Hysterectomized women |
1. Historia previa de reacción alérgica o hipersensibilidad a alguno de los componentes de la vacuna. 2. Historia previa de trastornos inmunes 3. En el momento de administrar la vacuna, enfermedad aguda grave con fiebre, excepto en caso de infección leve como una infección respiratoria leve del tracto respiratorio superior o de fiebre leve. Una vez superado, la vacuna puede ser administrada. 4. Administración de inmunoglobulina o productos derivados de la sangre en los 6 meses previos a la fecha programada para la primera dosis de vacuna. 5. Embarazo actual (reportado), lactancia o embarazo planeado en los próximos 12 meses. 6. Mujeres histerectomizadas |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Uptake of HPV vaccine in eligible women, by country and age strata |
Aceptabilidad de la vacuna frente a VPH en mujeres elegibles, por país y por grupo de edad |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Final del estudio |
|
E.5.2 | Secondary end point(s) |
Compliance of HPV vaccine administration schedule |
Adherencia al esquema de administración de la vacuna frente a VPH |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study |
Final del estudio |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Drug uptake Adherence to drug administration schedule |
|
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |