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 pre-malignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18. |
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E.1.1.1 | Medical condition in easily understood language |
Cervarix is a vaccine that protects women against infection caused by Human Papillomavirus (HPV) type 16 and type 18. These viruses can infect the skin or the genitals, which can lead to cancer. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063001 |
E.1.2 | Term | Human papilloma virus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of the HPV-015 study so that no cervical sample could be collected. |
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E.2.2 | Secondary objectives of the trial |
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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.
•A subject previously enrolled in the study HPV-015 and who fulfils either of the following criteria:
-displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding HPV-015 study visit
-was pregnant so that no cervical sample could be collected at her concluding HPV-015 study visit
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E.4 | Principal exclusion criteria |
•A subject who at the HPV-015 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
•A subject who at the HPV-015 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her HPV-015 exit colposcopy.
•A subject for whom the cervical cytology results from the concluding HPV-015 study visit were unavailable for reasons other than pregnancy.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV DNA testing (Hybrid Capture ® 2 test [HC2]).
•Occurrence of cervical cytological abnormalities in cervical samples by ThinPrep® PapTest.
•Occurrence of referral to colposcopy.
•Occurrence of referral to treatment.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 |
Canada |
Mexico |
Netherlands |
Peru |
Philippines |
Portugal |
Russian Federation |
Singapore |
Thailand |
United Kingdom |
United States |
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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 |