Oral persistent infection caused by any of the human papillomavirus types 16, 18, 31, 33, 45, 52, and 58 MedDRA version: 20.0 Level: LLT Classification code 10006524 Term: Buccal cavity papilloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: GARDASIL®9 (9vHPV vaccine)
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Is healthy and is judged to be in good physical health based on medical history and physical examination 2.Is male, from 20 years to 45 years of age inclusive, at the time of signing the informed consent 3.Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. 4.Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes 5.Can read, understand, and complete the eVRC 6.Has had at least 1 lifetime sexual partner Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV-related head and neck cancer 2.Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion (condyloma acuminata, penile intraepithelial neoplasia or penile cancer) 3.Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease 4.Has a fever (defined as oral temperature =100.0°F or =37.8°C) within the 24-hour period prior to the Day 1 visit* 5.Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention 6.Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for severe AEs or SAEs 7.Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections 8.Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition 9.Has a history of splenectomy 10.Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgement of investigator 11.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 or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use 12.Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (AravaTM), TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), IVIG, antilymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently (defined as within 2 weeks of Day 1 vaccination) received such therapy, or has received 2 or more courses of high-dose corticosteroids (=20 mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal, or topical steroids are considered eligible for the study. 13.Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product other than IVIG 14.Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate that a 3-dose regimen of the 9-valent human papillomavirus vaccine (9vHPV) vaccine will reduce the incidence of human papillomavirus (HPV)16/18/31/33/45/52/58-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age;Secondary Objective: - To demonstrate that a 3-dose regimen of the 9-valent human papillomavirus vaccine (9vHPV) vaccine will reduce the incidence of human papillomavirus (HPV) 6/11-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age. - To summarize antibody responses (Geometric Mean Titer [GMT] and seroconversion percentages) to each of human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 - To evaluate the safety and tolerability of the 9-valent human papillomavirus vaccine (9vHPV) vaccine when administered to males 20 to 45 years of age ;Primary end point(s): 1.Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection;Timepoint(s) of evaluation of this end point: 1.Up to Month 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection 2.Geometric Mean Titers to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies 3.Percentage of Participants who Seroconvert to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 4.Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE) 5.Percentage of Participants with Elevated Temperature (Fever) 6.Percentage of Participants who Report at Least 1 Systemic Adverse Event 7.Percentage of Participants who Experience at Least 1 Serious Adverse Event (SAE) 8.Percentage of Participants who Experience at Least 1 Serious Vaccine-Related Adverse Event ;Timepoint(s) of evaluation of this end point: 1.Up to Month 42 2.1 month postdose 3 (Month 7) 3.1 month postdose 3 (Month 7) 4.Up to 5 days after any vaccination 5.Up to 5 days after any vaccination 6.Up to 15 days after any vaccination 7.Up to 15 days after any vaccination 8.Up to Month 42 | — |
Countries
Belgium, Brazil, Colombia, Czechia, Czech Republic, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Spain, Taiwan, Thailand, United States
Contacts
Public ContactGlobal Clinical Trial Operation
Merck Sharp & Dohme Corp.
Outcome results
None listed