E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18. |
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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 provide clinical management and, if required, treatment to subjects who at the end of the HPV-008 study displayed normal cervical cytology but tested positive for oncogenic HPV infection or to subjects who were pregnant at the end of the HPV-008 study so that no cervical sample could be collected.
To report fatal serious adverse events (SAEs), SAEs related to study participation and SAEs related to a concurrent GSK medication in all subjects.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent obtained from the subject prior to enrolment. Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. A subject previously enrolled in the study HPV-008 and who fulfils either of the following criteria: displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48). or was pregnant at her last visit of the HPV-008 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
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E.4 | Principal exclusion criteria |
A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last HPV-008 study visit (Visit 10, Month 48). A subject who had a cervical lesion at her last HPV-008 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the HPV-008 exit colposcopy. A subject for whom the cervical cytology results from the last HPV-008 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing (Hybrid Capture® 2 test [HCII]). Evaluation of cervical cytological abnormalities in cervical samples by ThinPrep® PapTest. Occurrence of referral to colposcopy. Evaluation of colposcopy outcomes and biopsy results according to local laboratories. Occurrence of referrals to treatment. Evaluation of local cervical therapy performed and treatment biopsy results according to local laboratories. Occurrence of fatal SAEs. Occurrence and intensity of SAEs assessed as possibly related to study participation. Occurrence and intensity of SAEs assessed as possibly related to a concurrent GSK medication. Withdrawals from the study due to AEs and SAEs. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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) | 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 | 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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 52 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |