Spots Global Cancer Trial Database for Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
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Trial Identification
Brief Title: Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
Official Title: 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
Study ID: NCT04199689
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9-valent human papillomavirus (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 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
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, Bahia, Brazil
CPCLIN ( Site 0100), Natal, Rio Grande Do Norte, Brazil
Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102), Sao Paulo, , Brazil
Fundacion Centro de Investigacion Clinica CIC ( Site 0153), Medellin, Antioquia, Colombia
Clinica de la Costa Ltda. ( Site 0152), Barranquilla, Atlantico, Colombia
Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156), Chia, 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), Praha 2, , Czechia
FN Motol ( Site 0402), Praha 5, , Czechia
CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223), Dijon, Cote-d Or, France
Hopital Saint Eloi ( Site 0504), Montpellier, Herault, France
Hopital Cochin ( Site 0506), Paris, Ile-de-France, 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
Infektiologikum Frankfurt-Sachsenhausen ( Site 0456), Frankfurt am Main, Hessen, 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, Israel
Maccabi Health Services Medical Center ( Site 0604), Tel Aviv, HaMerkaz, 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), Padova, 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), Hachioji, 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
Korea University Ansan Hospital ( Site 0952), Ansan-si, Kyonggi-do, Korea, Republic of
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954), Seoul, , Korea, Republic of
Severance Hospital ( Site 0953), Seoul, , Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital ( Site 0951), Seoul, , Korea, Republic of
Korea University Guro Hospital ( Site 0950), Seoul, , Korea, Republic of
Instituto Nacional de Salud Publica ( Site 0202), Cuernavaca, Morelos, Mexico
Arke Estudios Clinicos S.A. de C.V. ( Site 0203), Cdmx, , Mexico
Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200), Chihuahua, , 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
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, , Taiwan
National Cheng Kung University Hospital ( Site 1002), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1000), Taipei, , Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 1001), Taoyuan, , Taiwan
Armed Forces Research Institute of Medical Sciences ( Site 1051), Bangkok, Krung Thep Maha Nakhon, Thailand
Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052), Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1050), Bangkok, Krung Thep Maha Nakhon, Thailand
Research Institute for Health Sciences ( Site 1053), Chiang Mai, , Thailand
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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