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. MedDRA version: 16.1 Level: PT Classification code 10061331 Term: Papilloma viral infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Human Papillomavirus 9-valent Vaccine, Recombinant
Product Code: V503
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Papillomavirus Type 6 L1 protein
Other desc
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
Male
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 75 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 425 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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-a 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, o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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®.;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 ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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. | — |
Countries
Belgium, Germany, Netherlands
Contacts
Public ContactJorien Karman
TFS BV
Outcome results
None listed