| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Prevention of Human Papillomavirus Infections | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.0 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10063001 | |
| 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 | Primary Safety Objective:
To demonstrate that a 3-dose regimen of quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when administered at 0, 2, and 6 months, is generally well tolerated in 16- to 23-year-old men.
Primary Efficacy Objective:
To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of HPV 6-, 11-, 16- or 18-related anogenital warts in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo.
MSM Substudy Efficacy Objective:
To investigate the impact of administration of a 3-dose regimen of quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine on the combined incidence of HPV 6-, 11-, 16-, or 18-related Anal Intraepithelial Neoplasia (AIN) or Anal Cancer in MSM subjects who are naïve to the relevant HPV type.
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| E.2.2 | Secondary objectives of the trial | Secondary Efficacy Objectives: (1) To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of persistent HPV 6, 11, 16, or 18 infection in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo (refer to Section I.F.1. for the definition of persistent infection). (2) To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of HPV 6, 11, 16, or 18 detection at one or more visits, in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo.
Immunogenicity Objective: To evaluate the vaccine-induced serum anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 responses in 16- to 23-year-old men.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | Inclusion Criteria for the study Vaccination Extension
a. No Temperature >= 100°F or >= 37.8°C (oral) within 24 hours prior to vaccination
b. Must agree to provide study personnel with a primary telephone number as well as an alternate numer for follow-up purposes
c. Must have received either the placebo or an incomplete series of HPV-vaccination in the original study, based on unblinding information provided to the Primary Investigator by the sponsor. | |
| E.4 | Principal exclusion criteria | Exclusion Criteria for the Study Vaccination Extension
a. History of known or prior vaccination with HPV-Vaccination (except for subjects who received an incomplete series, i.e. 1 or 2 doses, of HPV-Vaccination in the original study).
b. History of any condition that in the opinion of the Primary Investigaotr would contraindicated receipt of HPV-Vaccination
c. Inability to give informed consent.
d. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 21 days prior to enrollment. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | The primary endpoint is HPV 6-, 11-, 16-, 18-related anogenital warts. This endpoint will occur if there is:
–Pathology Panel consensus diagnosis of anogenital warts; AND
–Detection of HPV 6, 11, 16, or 18 DNA by Thinsection PCR in an adjacent section of the same external anogenital lesion biopsy block.
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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 | Yes |
| 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 | Information not present in EudraCT |
| 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) | 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 | 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 | |
| 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 | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 5 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 5 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
