Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
NCT ID: NCT04199689
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
6033 participants
INTERVENTIONAL
2020-02-27
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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9vHPV vaccine
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
9vHPV Vaccine
9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
Placebo
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Placebo (Saline for Injection)
0.9% sodium chloride given as a 0.5-mL intramuscular injection
Interventions
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9vHPV Vaccine
9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
Placebo (Saline for Injection)
0.9% sodium chloride given as a 0.5-mL intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgment of investigator
* Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use
* Has received within 12 months prior to enrollment, is receiving, or plans to receive during the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (ARAVA®), TNF-α antagonists, monoclonal antibody therapies (including rituximab \[RITUXAN®\]), intravenous immunoglobulin (IVIG), anti-lymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of high-dose corticosteroids (≥20 mg/day of prednisone \[or equivalent\] orally or parenterally) lasting at least 1 week in duration in the year prior. Participants using inhaled, nasal, or topical steroids are considered eligible for the study
* Has received within the 3 months prior to vaccination, is receiving, or plans to receive during the study, any immune globulin product (including RhoGAM™) or blood-derived product other than IVIG
* Has received inactivated or recombinant vaccines within 14 days prior to vaccination or receipt of live vaccines within 21 days prior to vaccination
* Is concurrently enrolled in other clinical studies of investigational agents
* Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo)
* Has engaged in sexual activity 48 hours prior to vaccination. Sexual activity is defined as: penile penetrative vaginal intercourse with female partner; penile penetrative or receptive anal intercourse with male or female partner; or oral sex involving any contact between participant's mouth with a female partner's vagina, genital or anal area or male partner's penis or genital or anal area. This also includes any contact between participant's partner's mouth with participant's penis, genital or anal area
* Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
Extension Study:
20 Years
45 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Cotton-O'Neil Clinical Research Center ( Site 0044)
Topeka, Kansas, United States
Heartland Research Associates, LLC ( Site 0034)
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research Inc ( Site 0011)
Bardstown, Kentucky, United States
Healthcare Research Network LLC ( Site 0035)
Hazelwood, Missouri, United States
Alliance for Multispecialty Reseach, LLC ( Site 0021)
Las Vegas, Nevada, United States
Certified Research Associates ( Site 0041)
Cortland, New York, United States
Laser Surgery Care ( Site 0018)
New York, New York, United States
Weill Cornell Medicine ( Site 0046)
New York, New York, United States
Rochester Clinical Research, Inc. ( Site 0008)
Rochester, New York, United States
PMG Research of Salisbury ( Site 0009)
Salisbury, North Carolina, United States
Rapid Medical Research, Inc. ( Site 0037)
Cleveland, Ohio, United States
Preferred Primary Care Physicians ( Site 0032)
Pittsburgh, Pennsylvania, United States
Coastal Carolina Research Center ( Site 0043)
North Charleston, South Carolina, United States
Holston Medical Group ( Site 0030)
Kingsport, Tennessee, United States
University of Texas Medical Branch at Galveston ( Site 0038)
Galveston, Texas, United States
Texas Center For Drug Development ( Site 0013)
Houston, Texas, United States
Crossroads Clinical Research LLC ( Site 0027)
Victoria, Texas, United States
J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)
Salt Lake City, Utah, United States
J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)
South Jordan, Utah, United States
Charlottesville Medical Research Center, LLC ( Site 0007)
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0015)
Newport News, Virginia, United States
Clinical Research Partners, LLC. ( Site 0004)
Richmond, Virginia, United States
University of Antwerp ( Site 0352)
Wilrijk, Antwerpen, Belgium
Universitair Ziekenhuis Gasthuisberg ( Site 0353)
Leuven, Vlaams-Brabant, Belgium
Femicare VZW ( Site 0350)
Tienen, Vlaams-Brabant, Belgium
Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)
Salvador, Estado de Bahia, Brazil
CPCLIN ( Site 0100)
Natal, Rio Grande do Norte, Brazil
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)
São Paulo, , Brazil
Fundacion Centro de Investigacion Clinica CIC ( Site 0153)
Medellín, Antioquia, Colombia
Clinica de la Costa Ltda. ( Site 0152)
Barranquilla, Atlántico, Colombia
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)
Chía, Cundinamarca, Colombia
Centrum ambulantni gynekologie a primarni pece ( Site 0401)
Brno, Brno-mesto, Czechia
G-CENTRUM Olomouc s.r.o. ( Site 0400)
Olomouc, , Czechia
MediStar s.r.o. ( Site 0403)
Prague, , Czechia
FN Motol ( Site 0402)
Prague, , Czechia
CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)
Dijon, Cote-d Or, France
Hopital Saint Eloi ( Site 0504)
Montpellier, Herault, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)
Rennes, Ille-et-Vilaine, France
CHU Nantes - Hopital Hotel Dieu ( Site 0510)
Nantes, Loire-Atlantique, France
Hopital Cochin ( Site 0506)
Paris, Île-de-France Region, France
Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)
Frankfurt am Main, Hesse, Germany
Epimed GmbH ( Site 0450)
Berlin, , Germany
Klinische Forschung Berlin ( Site 0454)
Berlin, , Germany
Universitatsklinikum Hamburg-Eppendorf ( Site 0451)
Hamburg, , Germany
Meir Medical Center ( Site 0602)
Kfar Saba, Central District, Israel
Maccabi Health Services Medical Center ( Site 0604)
Tel Aviv, Central District, Israel
Rambam Medical Center ( Site 0601)
Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0600)
Jerusalem, , Israel
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)
Rome, Roma, Italy
Azienda Ospedaliera - Universita di Padova ( Site 0555)
Padua, Veneto, Italy
Azienda Ospedaliera Policlinico di Bari ( Site 0550)
Bari, , Italy
AOU Policlinico Vittorio Emanuele ( Site 0552)
Catania, , Italy
Universita di Roma "La Sapienza" ( Site 0553)
Roma, , Italy
P-One Clinic, Keikokai Medical Corp. ( Site 1101)
Hachiōji, Tokyo, Japan
Sagiyama Urology Clinic ( Site 1116)
Fukuoka, , Japan
Souseikai PS Clinic ( Site 1103)
Fukuoka, , Japan
Souseikai Nishikumamoto Hospital ( Site 1104)
Kumamoto, , Japan
Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)
Osaka, , Japan
Nomura Clinic Namba ( Site 1114)
Osaka, , Japan
Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)
Osaka, , Japan
Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)
Tokyo, , Japan
Taisei Clinic ( Site 1109)
Tokyo, , Japan
Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)
Tokyo, , Japan
Naoko Dermatology Clinic ( Site 1107)
Tokyo, , Japan
Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)
Tokyo, , Japan
Medical Corporation Iseikai My City Clinic ( Site 1108)
Tokyo, , Japan
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)
Tokyo, , Japan
Kusunoki Clinic ( Site 1110)
Tokyo, , Japan
Arke Estudios Clinicos S.A. de C.V. ( Site 0203)
Mexico City, Mexico City, Mexico
Instituto Nacional de Salud Publica ( Site 0202)
Cuernavaca, Morelos, Mexico
Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)
Chihuahua City, , Mexico
ARKE Estudios Clinicos S.A de C.V ( Site 0211)
Veracruz, , Mexico
Asociacion Civil Selva Amazonica ( Site 0252)
Iquitos, Loreto, Peru
Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)
Lima, , Peru
Investigaciones Medicas en Salud - INMENSA ( Site 0255)
Lima, , Peru
Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)
Lima, , Peru
Asociacion Via Libre ( Site 0250)
Lima, , Peru
Korea University Ansan Hospital ( Site 0952)
Ansan-si, Kyonggi-do, South Korea
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)
Seoul, , South Korea
Severance Hospital ( Site 0953)
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital ( Site 0951)
Seoul, , South Korea
Korea University Guro Hospital ( Site 0950)
Seoul, , South Korea
Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)
Badalona, Barcelona, Spain
CAP Centelles ( Site 0751)
Centelles, Barcelona, Spain
ICO L Hospitalet ( Site 0754)
L'Hospitalet de Llobregat, Barcelona, Spain
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital ( Site 1002)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 1000)
Taipei, , Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 1001)
Taoyuan District, , Taiwan
Armed Forces Research Institute of Medical Sciences ( Site 1051)
Bangkok, Bangkok, Thailand
Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1050)
Bangkok, Bangkok, Thailand
Research Institute for Health Sciences ( Site 1053)
Chiang Mai, , Thailand
Countries
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References
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Giuliano AR. Initiation of three complementary international studies investigating prevalence of oral HPV infection, burden of HPV-related head and neck disease, and efficacy of 9-valent HPV vaccination against oral HPV persistent infection. Contemp Clin Trials. 2022 Apr;115:106629. doi: 10.1016/j.cct.2021.106629. Epub 2021 Nov 24. No abstract available.
Morais E, Kothari S, Roberts C, Yen G, Chen YT, Lynam M, Pedros M, Mirghani H, Alemany L, Pavon MA, Waterboer T, Mehanna H, Giuliano AR. Oral human papillomavirus (HPV) and associated factors among healthy populations: The design of the PROGRESS (PRevalence of Oral hpv infection, a Global aSSessment) study. Contemp Clin Trials. 2022 Apr;115:106630. doi: 10.1016/j.cct.2021.106630. Epub 2021 Nov 25.
Giuliano AR, Wilkin T, Bautista OM, Cheon K, Connor L, Dubey S; Thomas Group; Luxembourg A, Rawat S, Shaw A, Velicer C, Vendetti N, Tu Y. Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men. Contemp Clin Trials. 2022 Apr;115:106592. doi: 10.1016/j.cct.2021.106592. Epub 2021 Oct 19.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V503-049
Identifier Type: OTHER
Identifier Source: secondary_id
205346
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501974-21
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1275-8682
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-003236-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V503-049
Identifier Type: -
Identifier Source: org_study_id
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