E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 via concomitant administration of GARDASIL™ with prophylactic 5-valent HPV (Types 31, 33, 45, 52, 58) L1 virus-like particle (VLP) vaccine2. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063001 |
E.1.2 | Term | Human papilloma virus infection |
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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 |
1. To evaluate the tolerability of the 5-valent HPV L1 VLP vaccine when administered concomitantly with GARDASIL™ to 16- to 26-year-old women. 2. To demonstrate that administration of the 5-valent HPV L1 VLP vaccine concomitantly with GARDASIL™ (different injection sites in separate arms) induces non-inferior Geometric Mean Titers (GMTs) for anti-HPV 6, 11, 16, and 18 compared to GARDASIL™ administered concomitantly with placebo.
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E.2.2 | Secondary objectives of the trial |
To demonstrate that 5-valent HPV L1 VLP vaccine is immunogenic with respect to HPV types 31, 33, 45, 52, and 58.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of randomization. 2. Subject has never had Pap testing or has only had normal Pap test results. 3. The subject has had 0 to 4 male and/or female sexual partners. 4. Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).
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E.4 | Principal exclusion criteria |
1. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse). 2. Subject has a history of a positive test for HPV. 3. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. 4. Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG). 5. Subject has a history of or clinical evidence at the Day 1 pelvic examination of HPV-related external genital lesions (e.g., condyloma acuminata or vulvar intraepithelial neoplasia [VIN]) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata or vaginal intraepithelial neoplasia [VaIN]) or vaginal cancer. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The important variables for safety/tolerability are the incidences of severe injection-site reactions and any vaccine-related serious adverse experiences. The primary immunogenicity endpoints for the immunogenicity objectives are geometric mean titers (GMTs) to HPV 6, 11, 16, and 18 at Week 4 Postdose 3. The secondary endpoints are seroconversion percentages to HPV 31, 33, 45, 52 and 58 at Week 4 Postdose 3.
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |