| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer and genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Preventive treatment for HPV-virus, which may cause condyloma in women and men, or cancer in genital area in women. |
|
| 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 | 16.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061331 |
| E.1.2 | Term | Papilloma viral infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 |
| The primary objective is to demonstrate that administration of the 9vHPVvaccine induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL® in 16- to 26-year-old men. |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objectives are:
- To evaluate the tolerability of the 9vHPVvaccine in 16- to 26-year-old men.
- To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received 9vHPVvaccine or GARDASIL®. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
To be randomized and receive the first study vaccination, subjects must meet all inclusion criteria.
1. Subject is a man, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrolment.
2. Subject is a man who has had no more than 5 lifetime female sexual partners.
3. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
4. Subject, or subject's parent or guardian, fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent. |
|
| E.4 | Principal exclusion criteria |
To be randomized and receive the first study vaccination, subjects must not meet any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
1. Subject who has had sex with a male partner.
2. Subject has a history of HPV-related external genital lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma acuminata, anal intraepithelial neoplasia, or anal cancer).
3. Subject has a known allergy to any vaccine component, including aluminium, yeast, or BENZONASE® (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for serious adverse event as defined in Section 3.4.
4. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
5. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
6. Subject is concurrently enrolled in clinical studies of investigational medicinal products.
7. *Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
8. 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.
9. Subject has had a splenectomy.
10. Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab [MABTHERA®]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrolment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrolment. Subjects using inhaled, nasal or topical steroids are considered eligible for the study.
11. Subject has received any immune globulin product or blood-derived product within the 6 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
12. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
13. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
14. *Subject has had a fever (defined as an oral temperature of ≥37.8°C) within the 24-hour period prior to the Day 1 vaccination.
15. Subject has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
16. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
17. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
18. Subject, or subject's parent or guardian, is or has an immediate family member (spouse or children) who is investigational site or sponsor staff directly involved with this trial. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity: The cLIA geometric mean titres (GMTs) to HPV 6, 11, 16 and 18
Safety: Injection site adverse reactions and elevated temperatures, systemic adverse events and serious adverse events |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity: The cLIA geometric mean titres (GMTs) to HPV 6, 11, 16 and 18: 4 weeks post dose 3
Safety:
- Injection site adverse reactions and elevated temperatures: Day 1 to Day 5 post-vaccination
- Systemic adverse events Day 1 to Day 15 post-vaccination
- Serious adverse events will be collected from the time the consent is signed through 1 month following the last vaccination. |
|
| E.5.2 | Secondary end point(s) |
- The cLIA seroconversion percentages to HPV 6, 11, 16 and 18,
- The cLIA geometric mean titres (GMTs) and the cLIA seroconversion percentages to each of HPV 31, 33, 45, 52 and 58 in the 9vHPVgroup.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
- The cLIA seroconversion percentages to HPV 6, 11, 16 and 18: 4 weeks post dose 3,
- The cLIA geometric mean titres (GMTs) and the cLIA seroconversion percentages to each of HPV 31, 33, 45, 52 and 58: 4 weeks post dose 3 in the 9vHPVgroup.
|
|
| 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 |
|
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 7 |
| 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 | No |
| 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 | 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 |
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