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Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age

NCT04199689•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.

Eligibility

Age

20 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Base Study:
•Is healthy and is judged to be in good physical health based on medical history and physical examination
•Has provided written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
•Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes
•Can read, understand, and complete the electronic vaccination report card (eVRC)
•Has had at least 1 lifetime sexual partner
•Extension Study:
•Provides documented consent for the Extension Study

Exclusion Criteria

•Base Study:
•Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV related head and neck cancer
•Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion
•Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
•Has a fever (defined as oral temperature ≥100.0°F or ≥37.8°C) within a 24-hour period prior to Day 1 visit
•Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
•Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE®
•Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
•Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
•Has a history of splenectomy
+11 more criteria

Locations (103)

Valley Clinical Trials Inc. ( Site 0002)

Northridge, California, United States

Inland Empire Clinical Trials, LLC ( Site 0025)

Rialto, California, United States

Alta California Medical Group ( Site 0031)

Simi Valley, California, United States

Encompass Clinical Research ( Site 0028)

Spring Valley, California, United States

Diablo Clinical Research, Inc ( Site 0042)

Walnut Creek, California, United States

Clinical Research of South Florida ( Site 0036)

Coral Gables, Florida, United States

Acevedo Clinical Research Associates ( Site 0001)

Miami, Florida, United States

Moffitt Cancer Center ( Site 0017)

Tampa, Florida, United States

Augusta University ( Site 0010)

Augusta, Georgia, United States

Solaris Clinical Research, LLC ( Site 0003)

Meridian, Idaho, United States

Key Dates

Start Date

February 27, 2020

Primary Completion Date

August 27, 2027

Completion Date

August 31, 2028

Last Updated

March 25, 2025

Enrollment

6,033

ACTUAL participants

Conditions

Papillomavirus Infections

Interventions

9vHPV Vaccine

BIOLOGICAL

Placebo (Saline for Injection)

OTHER

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TERMINATEDPHASE1/PHASE2

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Inclusion Criteria

Exclusion Criteria

Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix

Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment

Prevalence and Longitudinal Follow-up of Anal Lesions, HPV Infection and Associated Sexually Transmitted Infections Among Men Who Have Sex With Men in Togo.

Community and Physician Perspectives Regarding Male Youth Human Papillomavirus (HPV) Disease and Vaccination

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)