A Phase 3 Open-Label Immunogenicity and Safety Study of 2-Dose Regimens of V503, a 9-Valent Human Papillomavirus (HPV) Vaccine in Chinese Males 9 Through 14 Years Old and 3-Dose Regimen of V503 in Chinese Males 9 Through 19 Years Old
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,590
- Locations
- 5
- Primary Endpoint
- Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
Study Overview
Brief Summary
This study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) in Chinese males 9 through 19 years of age, and 2 doses of the 9vHPV vaccine in Chinese males 9 through 14 years of age, compared to the 3 dose regimen in Chinese males 20 through 26 years of age (from Merck Protocol V503-052). The primary hypothesis is that each of the 3-dose regimen in Chinese males aged 9 through 19 years and 2-dose regimens in Chinese males aged 9 through 14 years induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) at one month post last dose compared to the 3-dose regimen in Chinese adult males aged 20 through 26 years. A noninferiority margin of 0.67 in the GMT ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each HPV type.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 19 Years (Child, Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Is a healthy Chinese male.
- •Has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (Day 1 through one month post last dose).
Exclusion Criteria
- •Has a history of known prior vaccination with an HPV vaccine.
- •Has a history of HPV-related external genital lesions, HPV-related intra-anal lesions, or HPV-related head and neck cancer.
- •Has a history of severe allergic reaction that required medical intervention.
- •Has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose.
- •Has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- •Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
- •Has a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
Outcomes
Primary Outcomes
Competitive Luminex immunoassay (cLIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose
Time Frame: Up to Month 13
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose
Time Frame: Up to 72 months
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine
Time Frame: Up to 72 months
cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.
Secondary Outcomes
- cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine(Up to Month 13)
- Percentage of participants experiencing serious AEs (SAEs)(Up to 72 months)
- IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine up to 60 months post last dose(Up to 72 months)
- Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose(Up to Month 13)
- IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine(Up to Month 13)
- Percentage of participants experiencing solicited injection-site adverse events (AEs),(Day 1 through Day 8 following any study vaccination)
- IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine(Up to 72 months)
- Percentage of participants experiencing solicited systemic AEs(Day 1 through Day 8 following any study vaccination)