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, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. |
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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 |
Safety in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASILTM |
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E.2.2 | Secondary objectives of the trial |
Demonstrate that the 9-valent HPV L1 VLP vaccine is immunogenic with respect to HPV Types 31, 33, 45, 52, and 58 in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASIL™.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject is a female, between the ages of 12 years and 0 days and 15 years and 364 days on the day of enrolment, or the subject is female between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment. 2. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent/assent. 3. Subject has received a 3-dose regimen of marketed GARDASILTM within a 1 year period as confirmed by medical or vaccination records including dates of administration. 4. Subject has received the third dose of GARDASILTM at least 1 year prior to Day 1. 5. Subjects age 12-15 years must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period. 6. Subjects age 16-26 have a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. 7. Subject has never had Pap testing or has only had normal Pap test results. 8. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
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E.4 | Principal exclusion criteria |
1. Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG). 2. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo. 3. Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens. 4. Subject has participated in a HPV vaccine clinical trial (whether receiving active agent or placebo). 5. Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). 6. Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition. 7. Subject has a history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia [CIN] or worse). Subject has a history 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) |
Safety: To evaluate the tolerability of the 9-valent HPV L1 VLP vaccine in adolescent girls 12 to 15 years of age and young women 16 to 26 y/o who have previously received GARDASILTM. Immunogenicity: The primary immunogenicity endpoints is the percentage of seropositivity to HPV 31, 33, 45, 52, and 58 at 4 weeks post dose 3. Other immunogenicity endpoints are geometric mean titers (GMTs) to HPV 31, 33, 45, 52, and 58 at 4 weeks post dose 3, GMTs and percentage of seropositivity to HPV 6, 11, 16, and 18 at 4 weeks post dose 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 | 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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |