E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cervical cancer: the study is conducted in healthy female adolescents |
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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 | 10021881 - Infections and infestations |
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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 compare between the HPV vaccine group and the control group (Havrix? recipients) the occurrence of serious adverse events (SAEs) throughout the study period (up to month 7). |
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E.2.2 | Secondary objectives of the trial |
Evaluate solicited local and general symptoms during the 7-days after vaccination & unsolicited symptoms during the 30-days after vaccination. Evaluate between the HPV vaccine and control groups occurrence of new onset chronic diseases and other medically significant conditions. Evaluate in pre-specified sites the effect of vaccination on biochemical & haematological parameters at months 0, 2 & 7. Evaluate in HPV vaccine recipients from pre-specified sites: antibody responses against HPV-16 & -18 and against MPL at months 0,2,7. Compare, one month after the third dose the immune responses to the HPV vaccine in healthy females aged 10?14 years in this study with responses from adults of the efficacy study 580299/001 (HPV-001). Compare between the HPV vaccine group and the control group the occurrence of SAEs, new onset chronic diseases and other medically significant conditions through the month 12 follow-up telephone call (annex analysis). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female subjects 10 ? 14 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.) |
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Pregnant or breastfeeding. Planning to become pregnant or likely to become pregnant. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of vaccination against hepatitis A or a known clinical history of hepatitis A infection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of SAEs throughout the study period (up to month 7). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study period (up to month 7) |
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E.5.2 | Secondary end point(s) |
?Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms within 7 days (days 0 ? 6) after each and any vaccination. ?Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms within 30 days (days 0 ? 29) after any vaccination. ?Occurrence of new onset chronic diseases (NOCDs) and other medically significant conditions (MSCs) prompting emergency room visits or physician visits that are not related to common diseases throughout the study period (up to month 7) regardless of causal relationship to vaccination and intensity. ?Occurrence of clinically relevant abnormalities in biochemical and haematological parameters (refer to section 5.6.2 for list of parameters) assessed at months 0, 2 and 7. ?Anti-HPV-16/18 antibody titres (by ELISA) assessed at months 0, 2 and 7. ?Anti-MPL® antibody titres (by ELISA) assessed at months 0, 2 and 7. ? Comparison of anti-HPV 16/18 antibody titres (by ELISA) assessed in sera from 10 ? 14 years old 580299/013 subjects and in sera from adults in study 580299/001 at month 7. ? Occurrence of SAEs, new onset chronic diseases and other medically significant conditions up to month 12 (extended safety follow-up). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Solicited symptoms: 7-day period following each vaccination Unsolicited symptoms: 30-day period following each vaccination NOCDs and MSCs: Throughout the study period (up to month 7) Biochemical and haematological parameters and ELISA: At months 0, 2 and 7 SAEs, NOCDs and MSCs: from month 7 to month 12 |
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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 | Yes |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
Australia |
Colombia |
Czech Republic |
France |
Germany |
Honduras |
Korea, Republic of |
Norway |
Panama |
Spain |
Sweden |
Taiwan |
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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 | 1 |
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 | 1 |
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 |