Efficacy, Immunogenicity, and Safety Study of the 9vHPV Vaccine in Japanese Males (V503-064)

NCT ID: NCT04635423

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1059 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2025-07-23

Brief Summary

The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) 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.

Conditions

Warts, Genital; Neoplasms, Anal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V503

Participants receive an intramuscular (IM) injection of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) at Day 1, Month 2, and Month 6.

Group Type: EXPERIMENTAL

V503

Intervention Type: BIOLOGICAL

9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.

Placebo

Participants receive an IM injection of placebo at Day 1, Month 2, and Month 6.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

0.9% sodium chloride (NaCL)

Interventions

V503

9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.

Intervention Type: BIOLOGICAL

Placebo

0.9% sodium chloride (NaCL)

Intervention Type: OTHER

Other Intervention Names

9vHPV vaccine; SILGARD®9; GARDASIL™9

Eligibility Criteria

Inclusion Criteria

• Is a Japanese male 16 to 26 years of age
• Has no more than 5 lifetime sexual partners

Exclusion Criteria

• Has a history of known prior vaccination with an HPV vaccine or plans to receive one outside the study
• Has a history of external genital warts
• Has a history of severe allergic reaction that required medical intervention
• 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 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 intramuscular injections
• Has ongoing alcohol or drug abuse within the past 12 months

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Umeyama Clinic ( Site 6406)

Takasaki, Gunma, Japan

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)

Kawasaki, Kanagawa, Japan

Ocean Clinic ( Site 6407)

Yokohama, Kanagawa, Japan

Kanno Clinic ( Site 6402)

Sakai, Osaka, Japan

P-One Clinic, Keikokai Medical Corp. ( Site 6419)

Hachiōji, Tokyo, Japan

Iwasa Clinic ( Site 6411)

Osaka, , Japan

Nomura Clinic Namba ( Site 6405)

Osaka, , Japan

Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)

Osaka, , Japan

Yamanaka Clinic ( Site 6410)

Osaka, , Japan

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)

Tokyo, , Japan

Yuge Clinic ( Site 6421)

Tokyo, , Japan

Taisei Clinic ( Site 6403)

Tokyo, , Japan

Mildix Skin Clinic ( Site 6423)

Tokyo, , Japan

Sugisawa Dermatology Clinic ( Site 6422)

Tokyo, , Japan

Medical Corporation Sanshikai Toru Clinic ( Site 6401)

Tokyo, , Japan

Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 6418)

Tokyo, , Japan

Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)

Tokyo, , Japan

Naoko Dermatology Clinic ( Site 6417)

Tokyo, , Japan

Medical Corporation Iseikai My City Clinic ( Site 6414)

Tokyo, , Japan

Shinjuku Higashiguchi Clinic ( Site 6415)

Tokyo, , Japan

Ogikuboekimae Clinic ( Site 6413)

Tokyo, , Japan

Kusunoki Clinic ( Site 6412)

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

V503-064

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031200217

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-001047-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V503-064

Identifier Type: -

Identifier Source: org_study_id