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

NCT04635423 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V503-064jRCT20312002172020-001047-67
• Study Type: interventional
• Target: 1,059
• Locations: 1 country
• Sites: 22

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

Outcome Measures

Primary Outcomes (5)

• Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection

  Combined incidence of HPV type(s) 6/11/16/18-related anogenital persistent infection was defined to have occurred in a participant; 1) who is polymerase chain reaction (PCR) positive to at least one applicable HPV type(s) in 2 consecutive anogenital or biopsy samples from at least 2 consecutive visits 6 months (±1 month visit) or longer apart, or 2) who has a pathology diagnosis of condyloma, penile/perineal/perianal intraepithelial neoplasia, or penile, perineal or perianal cancer and PCR detection of at least one applicable HPV type(s) in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit with regardless of visit interval, prior to or following the biopsy showing HPV disease. Incidence was defined as the number of cases per 100 person-years of follow-up in both V503 and placebo arms. Per protocol, cases per 100 person-years is reported for applicable HPV type eligible participants with data available in the per-protocol efficacy population (PPE).

  Up to approximately 36 Months

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, tenderness/pain, and swelling) is reported here for all randomized participants in the All Participants as Treated (APaT) population.

  Up to 5 days after any vaccination

• Percentage of Participants With ≥1 Systemic AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least 1 systemic AE is reported here for all randomized participants in the All Participants as Treated (APaT) population.

  Up to 15 days after any vaccination

• Percentage of Participants With ≥1 Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention, that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability/incapacity, is a congenital birth defect, or is another important medical event. The percentage of participants who experienced at least 1 SAE is reported here for all randomized participants in the All Participants as Treated (APaT) population.

  Up to approximately 37 months

• Number of Participants With Elevated Oral Body Temperature

  Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded using the vaccination report card (VRC). Per protocol, fever was defined as an oral temperature of ≥99.5°F(37.5°C). The number of participants who had at least 1 oral body temperature reading that was, \<99.5°F (\<37.5ºC), ≥99.5°F (≥37.5ºC) and \<100.4°F (38.0°C), or ≥100.4°F (38.0°C) and \<101.3°F(38.5°C), or ≥101.3°F(38.5°C) is reported here for all randomized participants in the APaT population with temperature data available.

  Up to 5 days after any vaccination

Secondary Outcomes (7)

• Combined Incidence of HPV 31/33/45/52/58-related Anogenital Persistent Infection

  Up to approximately 36 Months

• Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants

  Month 7

• Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Heterosexual Males (HM) Participant Subgroup

  Month 7

• Geometric Mean Titers (GMTs) to HPV 6/11/16/18/31/33/45/52/58 - Males Who Have Sex With Males (MSM) Participant Subgroup

  Month 7

• Percentage of Participants With Seroconversion to HPV 6/11/16/18/31/33/45/52/58 - All Randomized Participants

  Month 7

Study Arms (2)

V503

EXPERIMENTAL

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

Biological: V503

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

V503 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.

Also known as: 9vHPV vaccine, SILGARD®9, GARDASIL™9

V503

Placebo OTHER

0.9% sodium chloride (NaCL)

Placebo

Eligibility Criteria

• Age: 16 Years - 26 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (22)

Umeyama Clinic ( Site 6406)

Takasaki, Gunma, 370-0826, Japan

Location

Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 6424)

Kawasaki, Kanagawa, 210-0852, Japan

Location

Ocean Clinic ( Site 6407)

Yokohama, Kanagawa, 231-8331, Japan

Location

Kanno Clinic ( Site 6402)

Sakai, Osaka, 590-0024, Japan

Location

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

Hachiōji, Tokyo, 192-0071, Japan

Location

Iwasa Clinic ( Site 6411)

Osaka, 542-0073, Japan

Location

Nomura Clinic Namba ( Site 6405)

Osaka, 542-0076, Japan

Location

Medical Corporation Seiwakai Hayakawa Clinic ( Site 6409)

Osaka, 542-0086, Japan

Location

Yamanaka Clinic ( Site 6410)

Osaka, 553-0001, Japan

Location

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6404)

Tokyo, 101-0041, Japan

Location

Yuge Clinic ( Site 6421)

Tokyo, 103-0014, Japan

Location

Taisei Clinic ( Site 6403)

Tokyo, 107-0052, Japan

Location

Mildix Skin Clinic ( Site 6423)

Tokyo, 120-0034, Japan

Location

Sugisawa Dermatology Clinic ( Site 6422)

Tokyo, 125-0041, Japan

Location

Medical Corporation Sanshikai Toru Clinic ( Site 6401)

Tokyo, 132-0011, Japan

Location

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

Tokyo, 144-0051, Japan

Location

Seiyukai Medical Corporation Itoh Skin Clinic ( Site 6416)

Tokyo, 154-0024, Japan

Location

Naoko Dermatology Clinic ( Site 6417)

Tokyo, 158-0097, Japan

Location

Medical Corporation Iseikai My City Clinic ( Site 6414)

Tokyo, 160-0022, Japan

Location

Shinjuku Higashiguchi Clinic ( Site 6415)

Tokyo, 160-0022, Japan

Location

Ogikuboekimae Clinic ( Site 6413)

Tokyo, 167-0051, Japan

Location

Kusunoki Clinic ( Site 6412)

Tokyo, 175-0092, Japan

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Condylomata Acuminata; Anus Neoplasms

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 19, 2020
• Study Start: November 30, 2020
• Primary Completion: December 31, 2023
• Study Completion: July 23, 2025
• Last Updated: August 11, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (22)