NCT05314023Active, not recruitingPhase 3
Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053)
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
Source: ClinicalTrials.gov · Last updated 19 Jan 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1590 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- 7 May 2022
- Primary completion date
- 19 Feb 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05314023
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1590
- From 7 May 2022 to the primary completion date, 19 Feb 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of known prior vaccination with an HPV vaccine.
- 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 received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids.
Other illness
- 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 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 a known thrombocytopenia or coagulation disorder that would contraindicate IM injections.
Who the study is looking for
- 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).
Age in the registry: 9 years to 19 years · Sex: Male · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yuechi Disease Prevention and Control Center ( Site 0002) Coordinator of this site? Confirm its status | Guang’an | China | Unknown status |
| Liucheng County Centers for Disease Control and Prevention ( Site 0005) Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Center for Disease Control and Prevention of Rong An ( Site 0006) Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| Loudi Public Health Hospital (Loudi Occupational Disease Prevention And Treatment Hospital) ( Site 0 Coordinator of this site? Confirm its status | Louxing District | China | Unknown status |
| Santai County Center for Disease Control and Prevention ( Site 0001) Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.