Efficacité contre les infections orales persistantes, immunogénicité et innocuité du vaccin 9-valent contre le virus du papillome humain (9vHPV) chez les hommes âgés de 20 à 45 ans (V503-049)
17 octobre 2026 mis à jour par: Merck Sharp & Dohme LLC
Un essai clinique international de phase 3, multicentrique, randomisé, en double aveugle et contrôlé par placebo pour étudier l'efficacité, l'immunogénicité et l'innocuité du vaccin 9vHPV, un vaccin multivalent à particules de type virus L1, dans la prévention de la persistance orale Infection par les types de VPH 16, 18, 31, 33, 45, 52 ou 58 chez les hommes adultes de 20 à 45 ans
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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
6033
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 10787
- Epimed GmbH ( Site 0450)
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Berlin, Allemagne, 10787
- Klinische Forschung Berlin ( Site 0454)
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Hamburg, Allemagne, 20246
- Universitatsklinikum Hamburg-Eppendorf ( Site 0451)
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Hesse
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Frankfurt am Main, Hesse, Allemagne, 60596
- Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)
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Antwerpen
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Wilrijk, Antwerpen, Belgique, 2610
- University of Antwerp ( Site 0352)
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgique, 3000
- Universitair Ziekenhuis Gasthuisberg ( Site 0353)
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Tienen, Vlaams-Brabant, Belgique, 3300
- Femicare VZW ( Site 0350)
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São Paulo, Brésil, 05402-000
- Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)
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Estado de Bahia
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Salvador, Estado de Bahia, Brésil, 40415-006
- Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101)
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brésil, 59025-050
- CPCLIN ( Site 0100)
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Antioquia
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Medellín, Antioquia, Colombie, 050021
- Fundacion Centro de Investigacion Clinica CIC ( Site 0153)
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Atlántico
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Barranquilla, Atlántico, Colombie, 080020
- Clinica de la Costa Ltda. ( Site 0152)
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Cundinamarca
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Chía, Cundinamarca, Colombie, 250001
- Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156)
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Seoul, Corée du Sud, 03312
- The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954)
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Seoul, Corée du Sud, 03722
- Severance Hospital ( Site 0953)
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Seoul, Corée du Sud, 07441
- Hallym University Kangnam Sacred Heart Hospital ( Site 0951)
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Seoul, Corée du Sud, 08308
- Korea University Guro Hospital ( Site 0950)
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Kyonggi-do
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Ansan-si, Kyonggi-do, Corée du Sud, 15355
- Korea University Ansan Hospital ( Site 0952)
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Barcelona
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Badalona, Barcelona, Espagne, 08916
- Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755)
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Centelles, Barcelona, Espagne, 08540
- CAP Centelles ( Site 0751)
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L'Hospitalet de Llobregat, Barcelona, Espagne, 08090
- ICO L Hospitalet ( Site 0754)
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Cote-d Or
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Dijon, Cote-d Or, France, 21079
- CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223)
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Herault
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Montpellier, Herault, France, 34295
- Hopital Saint Eloi ( Site 0504)
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, France, 35033
- C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507)
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Loire-Atlantique
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Nantes, Loire-Atlantique, France, 44093
- CHU Nantes - Hopital Hotel Dieu ( Site 0510)
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Île-de-France Region
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Paris, Île-de-France Region, France, 75014
- Hopital Cochin ( Site 0506)
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Haifa, Israël, 3525408
- Rambam Medical Center ( Site 0601)
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Jerusalem, Israël, 9112001
- Hadassah Medical Center. Ein Kerem ( Site 0600)
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Central District
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Kfar Saba, Central District, Israël, 4428164
- Meir Medical Center ( Site 0602)
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Tel Aviv, Central District, Israël, 6789140
- Maccabi Health Services Medical Center ( Site 0604)
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Bari, Italie, 70124
- Azienda Ospedaliera Policlinico di Bari ( Site 0550)
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Catania, Italie, 95123
- AOU Policlinico Vittorio Emanuele ( Site 0552)
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Roma, Italie, 00161
- Universita di Roma "La Sapienza" ( Site 0553)
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Roma
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Rome, Roma, Italie, 00144
- Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551)
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Veneto
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Padova, Veneto, Italie, 35128
- Azienda Ospedaliera - Universita di Padova ( Site 0555)
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Fukuoka, Japon, 810-0001
- Sagiyama Urology Clinic ( Site 1116)
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Fukuoka, Japon, 812-0025
- Souseikai PS Clinic ( Site 1103)
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Kumamoto, Japon, 861-4157
- Souseikai Nishikumamoto Hospital ( Site 1104)
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Osaka, Japon, 532-0003
- Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)
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Osaka, Japon, 542-0076
- Nomura Clinic Namba ( Site 1114)
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Osaka, Japon, 542-0086
- Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)
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Tokyo, Japon, 101-0041
- Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111)
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Tokyo, Japon, 107-0052
- Taisei Clinic ( Site 1109)
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Tokyo, Japon, 144-0051
- Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112)
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Tokyo, Japon, 158-0097
- Naoko Dermatology Clinic ( Site 1107)
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Tokyo, Japon, 160-0017
- Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)
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Tokyo, Japon, 160-0022
- Medical Corporation Iseikai My City Clinic ( Site 1108)
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Tokyo, Japon, 171-0014
- Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)
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Tokyo, Japon, 175-0092
- Kusunoki Clinic ( Site 1110)
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Tokyo
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Hachiōji, Tokyo, Japon, 192-0071
- P-One Clinic, Keikokai Medical Corp. ( Site 1101)
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Chihuahua City, Mexique, 31000
- Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)
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Veracruz, Mexique, 91910
- ARKE Estudios Clinicos S.A de C.V ( Site 0211)
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Mexico City
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Mexico City, Mexico City, Mexique, 06700
- Arke Estudios Clinicos S.A. de C.V. ( Site 0203)
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Morelos
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Cuernavaca, Morelos, Mexique, 62100
- Instituto Nacional de Salud Publica ( Site 0202)
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Lima, Pérou, 07006
- Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)
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Lima, Pérou, 15046
- Investigaciones Medicas en Salud - INMENSA ( Site 0255)
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Lima, Pérou, 15423
- Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)
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Lima, Pérou, LIMA 01
- Asociacion Via Libre ( Site 0250)
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Loreto
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Iquitos, Loreto, Pérou, 16000
- Asociacion Civil Selva Amazonica ( Site 0252)
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Kaohsiung City, Taïwan, 833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)
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Tainan, Taïwan, 70403
- National Cheng Kung University Hospital ( Site 1002)
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Taipei, Taïwan, 100
- National Taiwan University Hospital ( Site 1000)
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Taoyuan, Taïwan, 333
- Chang Gung Medical Foundation.Linkou Branch ( Site 1001)
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Olomouc, Tchéquie, 772 00
- G-CENTRUM Olomouc s.r.o. ( Site 0400)
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Prague, Tchéquie, 120 00
- MediStar s.r.o. ( Site 0403)
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Prague, Tchéquie, 150 06
- FN Motol ( Site 0402)
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Brno-mesto
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Brno, Brno-mesto, Tchéquie, 602 00
- Centrum ambulantni gynekologie a primarni pece ( Site 0401)
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Chiang Mai, Thaïlande, 50200
- Research Institute for Health Sciences ( Site 1053)
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Bangkok
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Bangkok, Bangkok, Thaïlande, 10400
- Armed Forces Research Institute of Medical Sciences ( Site 1051)
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Bangkok, Bangkok, Thaïlande, 10400
- Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)
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Bangkok, Bangkok, Thaïlande, 10700
- Faculty of Medicine Siriraj Hospital ( Site 1050)
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California
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Northridge, California, États-Unis, 91325
- Valley Clinical Trials Inc. ( Site 0002)
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Rialto, California, États-Unis, 92377
- Inland Empire Clinical Trials, LLC ( Site 0025)
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Simi Valley, California, États-Unis, 93065
- Alta California Medical Group ( Site 0031)
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Spring Valley, California, États-Unis, 91978
- Encompass Clinical Research ( Site 0028)
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Walnut Creek, California, États-Unis, 94598
- Diablo Clinical Research, Inc ( Site 0042)
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Florida
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Coral Gables, Florida, États-Unis, 33134
- Clinical Research of South Florida ( Site 0036)
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Miami, Florida, États-Unis, 33142
- Acevedo Clinical Research Associates ( Site 0001)
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Tampa, Florida, États-Unis, 33617
- Moffitt Cancer Center ( Site 0017)
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Georgia
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Augusta, Georgia, États-Unis, 30912
- Augusta University ( Site 0010)
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Idaho
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Meridian, Idaho, États-Unis, 83646
- Solaris Clinical Research, LLC ( Site 0003)
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Kansas
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Topeka, Kansas, États-Unis, 66606
- Cotton-O'Neil Clinical Research Center ( Site 0044)
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Wichita, Kansas, États-Unis, 67207
- Heartland Research Associates, LLC ( Site 0034)
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Kentucky
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Bardstown, Kentucky, États-Unis, 40004
- Kentucky Pediatric/Adult Research Inc ( Site 0011)
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Missouri
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Hazelwood, Missouri, États-Unis, 63042
- Healthcare Research Network LLC ( Site 0035)
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Nevada
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Las Vegas, Nevada, États-Unis, 89119
- Alliance for Multispecialty Reseach, LLC ( Site 0021)
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New York
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Cortland, New York, États-Unis, 13045
- Certified Research Associates ( Site 0041)
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New York, New York, États-Unis, 10011
- Laser Surgery Care ( Site 0018)
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New York, New York, États-Unis, 10065
- Weill Cornell Medicine ( Site 0046)
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Rochester, New York, États-Unis, 14609
- Rochester Clinical Research, Inc. ( Site 0008)
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North Carolina
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Salisbury, North Carolina, États-Unis, 28144
- PMG Research of Salisbury ( Site 0009)
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Ohio
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Cleveland, Ohio, États-Unis, 44122
- Rapid Medical Research, Inc. ( Site 0037)
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15236
- Preferred Primary Care Physicians ( Site 0032)
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South Carolina
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North Charleston, South Carolina, États-Unis, 29405
- Coastal Carolina Research Center ( Site 0043)
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Tennessee
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Kingsport, Tennessee, États-Unis, 37660
- Holston Medical Group ( Site 0030)
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Texas
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Galveston, Texas, États-Unis, 77555-1115
- University of Texas Medical Branch at Galveston ( Site 0038)
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Houston, Texas, États-Unis, 77081
- Texas Center For Drug Development ( Site 0013)
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Victoria, Texas, États-Unis, 77901
- Crossroads Clinical Research LLC ( Site 0027)
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Utah
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Salt Lake City, Utah, États-Unis, 84121
- J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)
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South Jordan, Utah, États-Unis, 84095
- J Lewis Research Inc/Jordan River Family Medicine ( Site 0023)
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Virginia
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Charlottesville, Virginia, États-Unis, 22911
- Charlottesville Medical Research Center, LLC ( Site 0007)
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Newport News, Virginia, États-Unis, 23606
- Health Research of Hampton Roads, Inc. ( Site 0015)
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Richmond, Virginia, États-Unis, 23226
- Clinical Research Partners, LLC. ( Site 0004)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Homme
La description
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:
- Participants may continue in the Extension Study if Inclusion Criteria #1 and #4 are still met, and the participants was in either the placebo group in the Base Study or the vaccine group in the Base Study but did not complete the vaccination series
- 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
- 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:
- Participants must be excluded from the Extension Study if Base Study Exclusion Criteria #4, 5, 6, 7, 10, 16, or 18 are met
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 9vHPV vaccine
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 |
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.
Autres noms:
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Comparateur placebo: Placebo
Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 |
0.9% sodium chloride given as a 0.5-mL intramuscular injection |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
Délai: Up to Month 90
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A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart. |
Up to Month 90
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of HPV 6/11-related 6-month Persistent Oral Infection
Délai: Up to Month 90
|
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV PCR assay to at least 1 common gene in ORG samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart. |
Up to Month 90
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Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
Délai: 1 month postdose 3 (Month 7)
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Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers. |
1 month postdose 3 (Month 7)
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Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Délai: 1 month postdose 3 (Month 7)
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Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV cLIA titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type. |
1 month postdose 3 (Month 7)
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Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
Délai: Up to 5 days after any vaccination
|
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded. |
Up to 5 days after any vaccination
|
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Percentage of Participants with Elevated Temperature (Fever)
Délai: Up to 5 days after any vaccination
|
Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed. |
Up to 5 days after any vaccination
|
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Percentage of Participants Who Report at Least 1 Systemic AE
Délai: Up to 15 days after any vaccination
|
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. |
Up to 15 days after any vaccination
|
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Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
Délai: Up to 15 days after any vaccination
|
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. |
Up to 15 days after any vaccination
|
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Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE
Délai: Up to Month 90
|
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period. |
Up to Month 90
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Merck Sharp & Dohme LLC
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 février 2020
Achèvement primaire (Estimé)
15 janvier 2027
Achèvement de l'étude (Estimé)
13 août 2027
Dates d'inscription aux études
Première soumission
12 décembre 2019
Première soumission répondant aux critères de contrôle qualité
12 décembre 2019
Première publication (Réel)
16 décembre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Processus pathologiques
- Attributs de la maladie
- Infections
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections par le virus de l'ADN
- Infections virales tumorales
- Conditions pathologiques, signes et symptômes
- Infections à papillomavirus
- Thérapeutique
- Voies d'administration du médicament
- Pharmacothérapie
- Produits chimiques inorganiques
- Composés de chlore
- Composés de sodium
- Chlorures
- Acide chlorhydrique
- Injections
- Chlorure de sodium
Autres numéros d'identification d'étude
- V503-049
- V503-049 (Autre identifiant: MSD)
- 205346 (Identificateur de registre: JAPIC-CTI)
- U1111-1275-8682 (Identificateur de registre: UTN)
- 2019 (Subvention/contrat des NIH des États-Unis)
- 2022-501974-21-00 (Identificateur de registre: EU CT)
- 2019-003236-23 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .