E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to 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 evaluate the long-term immunogenicity of the HPV-16/18 vaccine by enzyme-linked immunosorbent assay (ELISA). |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the long-term safety of the HPV-16/18 vaccine. • To evaluate the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 ELISA) in subjects in this study versus the immune responses to the HPV-16/18 vaccine in young women in the efficacy studies HPV-001/HPV-007/HPV-023 at equivalent time points. • To evaluate the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 ELISA) in subjects in this study versus the immune responses elicited after natural infection. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects who the investigator believes that they and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. • A female enrolled in the immunogenicity subset of study HPV-013, who received three doses of HPV-16/18 VLP/AS04 vaccine and participated in the long-term follow-up study Ext HPV-013. • Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or LAR and, in addition, the subject should sign a written informed assent form.
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E.4 | Principal exclusion criteria |
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). • Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. • Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/-18 vaccine administered in study HPV-013. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. (For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.) • Administration of immunoglobulins and/or any blood products within the three months preceding study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Anti-HPV-16/18 antibody titres and seroconversion rates (ELISA). |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 24 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
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 | Yes |
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 | 6 |
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 | 6 |
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 |