NCT04635423CompletedPhase 3
Efficacy, Immunogenicity, and Safety Study of V503 (9-valent Human Papillomavirus [9vHPV] Vaccine) in Japanese Males (V503-064)
A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age.
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1059 (actual)
- First submitted
- 5 Nov 2020
- Start date
- 30 Nov 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Childhood cancers
- NCT number
- NCT04635423
- EudraCT number
- 2020-001047-67
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1059
- From 30 Nov 2020 to the primary completion date, 31 Dec 2023
- 22 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 or plans to receive one outside the study
- Has received immune globulin or blood-derived products in the past 3 months or plan to receive any before Month 7 of the study
- Has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
- Has ongoing alcohol or drug abuse within the past 12 months
Other illness
- Has a history of external genital warts
- 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 intramuscular injections
Who the study is looking for
- Is a Japanese male 16 to 26 years of age
- Has no more than 5 lifetime sexual partners
Age in the registry: 16 years to 26 years · Sex: Male · Accepts healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| P-One Clinic, Keikokai Medical Corp. ( Site 6419) Coordinator of this site? Confirm its status | Hachiōji | Japan | Unknown status |
| Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424) Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Yamanaka Clinic ( Site 6410) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Nomura Clinic Namba ( Site 6405) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Iwasa Clinic ( Site 6411) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kanno Clinic ( Site 6402) Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Umeyama Clinic ( Site 6406) Coordinator of this site? Confirm its status | Takasaki | Japan | Unknown status |
| Taisei Clinic ( Site 6403) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Medical Corporation Sanshikai Toru Clinic ( Site 6401) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Sugisawa Dermatology Clinic ( Site 6422) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kusunoki Clinic ( Site 6412) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Mildix Skin Clinic ( Site 6423) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Medical Corporation Iseikai My City Clinic ( Site 6414) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Yuge Clinic ( Site 6421) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ogikuboekimae Clinic ( Site 6413) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Naoko Dermatology Clinic ( Site 6417) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Shinjuku Higashiguchi Clinic ( Site 6415) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ocean Clinic ( Site 6407) Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
Related publications
- Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.Cochrane Database Syst Rev · 2025 · PMID 41276263
This page is information, not medical advice. Discuss any trial with your doctor.