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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

6,033

Participants

Timeline

Start Date

February 27, 2020

Primary Completion Date

August 27, 2027

Study Completion Date

August 31, 2028

Conditions
Papillomavirus Infections
Interventions
BIOLOGICAL

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.

OTHER

Placebo (Saline for Injection)

0.9% sodium chloride given as a 0.5-mL intramuscular injection

Trial Locations (103)

100

National Taiwan University Hospital ( Site 1000), Taipei

333

Chang Gung Medical Foundation.Linkou Branch ( Site 1001), Taoyuan District

833

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003), Kaohsiung City

2610

University of Antwerp ( Site 0352), Wilrijk

3000

Universitair Ziekenhuis Gasthuisberg ( Site 0353), Leuven

3300

Femicare VZW ( Site 0350), Tienen

10011

Laser Surgery Care ( Site 0018), New York

10065

Weill Cornell Medicine ( Site 0046), New York

10400

Armed Forces Research Institute of Medical Sciences ( Site 1051), Bangkok

Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052), Bangkok

10700

Faculty of Medicine Siriraj Hospital ( Site 1050), Bangkok

10787

Epimed GmbH ( Site 0450), Berlin

Klinische Forschung Berlin ( Site 0454), Berlin

13045

Certified Research Associates ( Site 0041), Cortland

14609

Rochester Clinical Research, Inc. ( Site 0008), Rochester

15046

Investigaciones Medicas en Salud - INMENSA ( Site 0255), Lima

15236

Preferred Primary Care Physicians ( Site 0032), Pittsburgh

15355

Korea University Ansan Hospital ( Site 0952), Ansan-si

15423

Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251), Lima

16000

Asociacion Civil Selva Amazonica ( Site 0252), Iquitos

20246

Universitatsklinikum Hamburg-Eppendorf ( Site 0451), Hamburg

21079

CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0223), Dijon

22911

Charlottesville Medical Research Center, LLC ( Site 0007), Charlottesville

23226

Clinical Research Partners, LLC. ( Site 0004), Richmond

23606

Health Research of Hampton Roads, Inc. ( Site 0015), Newport News

28144

PMG Research of Salisbury ( Site 0009), Salisbury

29405

Coastal Carolina Research Center ( Site 0043), North Charleston

30912

Augusta University ( Site 0010), Augusta

31000

Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200), Chihuahua City

33134

Clinical Research of South Florida ( Site 0036), Coral Gables

33142

Acevedo Clinical Research Associates ( Site 0001), Miami

33617

Moffitt Cancer Center ( Site 0017), Tampa

34295

Hopital Saint Eloi ( Site 0504), Montpellier

35033

C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0507), Rennes

35128

Azienda Ospedaliera - Universita di Padova ( Site 0555), Padua

37660

Holston Medical Group ( Site 0030), Kingsport

40004

Kentucky Pediatric/Adult Research Inc ( Site 0011), Bardstown

44093

CHU Nantes - Hopital Hotel Dieu ( Site 0510), Nantes

44122

Rapid Medical Research, Inc. ( Site 0037), Cleveland

50200

Research Institute for Health Sciences ( Site 1053), Chiang Mai

60596

Infektiologikum Frankfurt-Sachsenhausen ( Site 0456), Frankfurt am Main

62100

Instituto Nacional de Salud Publica ( Site 0202), Cuernavaca

63042

Healthcare Research Network LLC ( Site 0035), Hazelwood

66606

Cotton-O'Neil Clinical Research Center ( Site 0044), Topeka

67207

Heartland Research Associates, LLC ( Site 0034), Wichita

70124

Azienda Ospedaliera Policlinico di Bari ( Site 0550), Bari

70403

National Cheng Kung University Hospital ( Site 1002), Tainan City

75014

Hopital Cochin ( Site 0506), Paris

77081

Texas Center For Drug Development ( Site 0013), Houston

77901

Crossroads Clinical Research LLC ( Site 0027), Victoria

83646

Solaris Clinical Research, LLC ( Site 0003), Meridian

84095

J Lewis Research Inc/Jordan River Family Medicine ( Site 0023), South Jordan

84121

J Lewis Research Inc/Foothill Family Clinic South ( Site 0006), Salt Lake City

89119

Alliance for Multispecialty Reseach, LLC ( Site 0021), Las Vegas

91325

Valley Clinical Trials Inc. ( Site 0002), Northridge

91910

ARKE Estudios Clinicos S.A de C.V ( Site 0211), Veracruz

91978

Encompass Clinical Research ( Site 0028), Spring Valley

92377

Inland Empire Clinical Trials, LLC ( Site 0025), Rialto

93065

Alta California Medical Group ( Site 0031), Simi Valley

94598

Diablo Clinical Research, Inc ( Site 0042), Walnut Creek

95123

AOU Policlinico Vittorio Emanuele ( Site 0552), Catania

250001

Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0156), Chía

3525408

Rambam Medical Center ( Site 0601), Haifa

4428164

Meir Medical Center ( Site 0602), Kfar Saba

6789140

Maccabi Health Services Medical Center ( Site 0604), Tel Aviv

9112001

Hadassah Medical Center. Ein Kerem ( Site 0600), Jerusalem

77555-1115

University of Texas Medical Branch at Galveston ( Site 0038), Galveston

40415-006

Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0101), Salvador

59025-050

CPCLIN ( Site 0100), Natal

05402-000

Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102), São Paulo

050021

Fundacion Centro de Investigacion Clinica CIC ( Site 0153), Medellín

080020

Clinica de la Costa Ltda. ( Site 0152), Barranquilla

602 00

Centrum ambulantni gynekologie a primarni pece ( Site 0401), Brno

772 00

G-CENTRUM Olomouc s.r.o. ( Site 0400), Olomouc

120 00

MediStar s.r.o. ( Site 0403), Prague

150 06

FN Motol ( Site 0402), Prague

00144

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0551), Rome

00161

"Universita di Roma La Sapienza ( Site 0553)", Roma

192-0071

P-One Clinic, Keikokai Medical Corp. ( Site 1101), Hachiōji

810-0001

Sagiyama Urology Clinic ( Site 1116), Fukuoka

812-0025

Souseikai PS Clinic ( Site 1103), Fukuoka

861-4157

Souseikai Nishikumamoto Hospital ( Site 1104), Kumamoto

532-0003

Medical Corporation Heishinkai OPHAC Hospital ( Site 1105), Osaka

542-0076

Nomura Clinic Namba ( Site 1114), Osaka

542-0086

Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113), Osaka

101-0041

Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 1111), Tokyo

107-0052

Taisei Clinic ( Site 1109), Tokyo

144-0051

Medical Corporation Mori to Umi Tokyo Tokyo Kamata Hospital ( Site 1112), Tokyo

158-0097

Naoko Dermatology Clinic ( Site 1107), Tokyo

160-0017

Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106), Tokyo

160-0022

Medical Corporation Iseikai My City Clinic ( Site 1108), Tokyo

171-0014

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102), Tokyo

175-0092

Kusunoki Clinic ( Site 1110), Tokyo

06700

Arke Estudios Clinicos S.A. de C.V. ( Site 0203), Mexico City

07006

Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257), Lima

LIMA 01

Asociacion Via Libre ( Site 0250), Lima

03312

The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 0954), Seoul

03722

Severance Hospital ( Site 0953), Seoul

07441

Hallym University Kangnam Sacred Heart Hospital ( Site 0951), Seoul

08308

Korea University Guro Hospital ( Site 0950), Seoul

08916

Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0755), Badalona

08540

CAP Centelles ( Site 0751), Centelles

08090

ICO L Hospitalet ( Site 0754), L'Hospitalet de Llobregat

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY