E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For active immunization of women from the age of 10 years onwards to prevent 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 evaluate the long-term immunogenicity of the HPV 16/18 vaccine in serum from all subjects by enzyme-linked immunosorbent assay (ELISA) at Years 5, 6, 7, 8, 9 and 10. |
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E.2.2 | Secondary objectives of the trial |
In serum samples collected at Years 5, 6, 7, 8, 9 and 10: • To compare the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) to levels in efficacy studies HPV 001, HPV-007 and HPV-023 at equivalent time points. • To compare the immune responses to the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) to levels after natural infection from study HPV-008. • To evaluate total immunoglobulin G (IgG).
In cervico-vaginal secretion (CVS) samples collected from subjects who volunteer at Years 5, 6, 7, 8, 9 and 10: • To evaluate anti-HPV-16 and anti-HPV-18 antibody levels. • To compare anti-HPV-16 and anti-HPV-18 antibody levels in CVS samples with antibody levels in serum samples. • To evaluate total IgG.
• To evaluate the long-term safety of the HPV-16/18 vaccine up to approximately 10 years after administration of the first vaccine dose. |
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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 can and will comply with the requirements of the protocol. • A female who enrolled in study HPV-014 and received three doses of HPV-16/18 vaccine. • Written informed consent obtained from the subject.
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E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. • Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. For corticosteroids, this will mean prednisone, >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • 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). • Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. • Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in study HPV 014. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Evaluation of immune responses to components of the vaccine in serum of all subjects at Years 5, 6, 7, 8, 9 and 10: - Anti-HPV-16 and anti-HPV-18 antibody titres by ELISA, - Seroconversion rates by 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 | Yes |
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 | 6 |
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 | Information not present in EudraCT |
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 | 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 |