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Papillomavirus InfectionsPhase 3NCT04199689

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 study testing 9vHPV Vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 103 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Papillomavirus Infections
What is being tested?
9vHPV Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,033 participants
Where
103 sitesin 16 countries
Study dates
27 Feb 2020to 13 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

103 sites in 16 countries.

103 sites in 16 countries

United States32 sites

  • Augusta University ( Site 0010)

    Augusta, Georgia, 30912

  • Kentucky Pediatric/Adult Research Inc ( Site 0011)

    Bardstown, Kentucky, 40004

  • Charlottesville Medical Research Center, LLC ( Site 0007)

    Charlottesville, Virginia, 22911

  • Rapid Medical Research, Inc. ( Site 0037)

    Cleveland, Ohio, 44122

  • Clinical Research of South Florida ( Site 0036)

    Coral Gables, Florida, 33134

  • Certified Research Associates ( Site 0041)

    Cortland, New York, 13045

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

    Galveston, Texas, 77555-1115

  • Healthcare Research Network LLC ( Site 0035)

    Hazelwood, Missouri, 63042

  • Texas Center For Drug Development ( Site 0013)

    Houston, Texas, 77081

  • Holston Medical Group ( Site 0030)

    Kingsport, Tennessee, 37660

  • Alliance for Multispecialty Reseach, LLC ( Site 0021)

    Las Vegas, Nevada, 89119

  • Solaris Clinical Research, LLC ( Site 0003)

    Meridian, Idaho, 83646

  • Acevedo Clinical Research Associates ( Site 0001)

    Miami, Florida, 33142

  • Laser Surgery Care ( Site 0018)

    New York, New York, 10011

  • Weill Cornell Medicine ( Site 0046)

    New York, New York, 10065

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

    Newport News, Virginia, 23606

  • Coastal Carolina Research Center ( Site 0043)

    North Charleston, South Carolina, 29405

  • Valley Clinical Trials Inc. ( Site 0002)

    Northridge, California, 91325

  • Preferred Primary Care Physicians ( Site 0032)

    Pittsburgh, Pennsylvania, 15236

  • Inland Empire Clinical Trials, LLC ( Site 0025)

    Rialto, California, 92377

  • Clinical Research Partners, LLC. ( Site 0004)

    Richmond, Virginia, 23226

  • Rochester Clinical Research, Inc. ( Site 0008)

    Rochester, New York, 14609

  • PMG Research of Salisbury ( Site 0009)

    Salisbury, North Carolina, 28144

  • J Lewis Research Inc/Foothill Family Clinic South ( Site 0006)

    Salt Lake City, Utah, 84121

  • Alta California Medical Group ( Site 0031)

    Simi Valley, California, 93065

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

    South Jordan, Utah, 84095

  • Encompass Clinical Research ( Site 0028)

    Spring Valley, California, 91978

  • Moffitt Cancer Center ( Site 0017)

    Tampa, Florida, 33617

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

    Topeka, Kansas, 66606

  • Crossroads Clinical Research LLC ( Site 0027)

    Victoria, Texas, 77901

  • Diablo Clinical Research, Inc ( Site 0042)

    Walnut Creek, California, 94598

  • Heartland Research Associates, LLC ( Site 0034)

    Wichita, Kansas, 67207

Other trials in United States

Japan15 sites

  • Sagiyama Urology Clinic ( Site 1116)

    Fukuoka, 810-0001

  • Souseikai PS Clinic ( Site 1103)

    Fukuoka, 812-0025

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

    Hachiōji, Tokyo, 192-0071

  • Souseikai Nishikumamoto Hospital ( Site 1104)

    Kumamoto, 861-4157

  • Medical Corporation Heishinkai OPHAC Hospital ( Site 1105)

    Osaka, 532-0003

  • Nomura Clinic Namba ( Site 1114)

    Osaka, 542-0076

  • Medical Corporation Seiwakai Hayakawa Clinic ( Site 1113)

    Osaka, 542-0086

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

    Tokyo, 101-0041

  • Taisei Clinic ( Site 1109)

    Tokyo, 107-0052

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

    Tokyo, 144-0051

  • Naoko Dermatology Clinic ( Site 1107)

    Tokyo, 158-0097

  • Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1106)

    Tokyo, 160-0017

  • Medical Corporation Iseikai My City Clinic ( Site 1108)

    Tokyo, 160-0022

  • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1102)

    Tokyo, 171-0014

  • Kusunoki Clinic ( Site 1110)

    Tokyo, 175-0092

Other trials in Japan

France5 sites

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

    Dijon, Cote-d Or, 21079

  • Hopital Saint Eloi ( Site 0504)

    Montpellier, Herault, 34295

  • CHU Nantes - Hopital Hotel Dieu ( Site 0510)

    Nantes, Loire-Atlantique, 44093

  • Hopital Cochin ( Site 0506)

    Paris, Île-de-France Region, 75014

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

    Rennes, Ille-et-Vilaine, 35033

Other trials in France

Italy5 sites

  • Azienda Ospedaliera Policlinico di Bari ( Site 0550)

    Bari, 70124

  • AOU Policlinico Vittorio Emanuele ( Site 0552)

    Catania, 95123

  • Azienda Ospedaliera - Universita di Padova ( Site 0555)

    Padova, Veneto, 35128

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

    Roma, 00161

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

    Rome, Roma, 00144

Other trials in Italy

Peru5 sites

  • Asociacion Civil Selva Amazonica ( Site 0252)

    Iquitos, Loreto, 16000

  • Policlinico Universidad Nacional Mayor de San Marcos ( Site 0257)

    Lima, 07006

  • Investigaciones Medicas en Salud - INMENSA ( Site 0255)

    Lima, 15046

  • Instituto de Investigacion Nutricional - Anexo Huascar ( Site 0251)

    Lima, 15423

  • Asociacion Via Libre ( Site 0250)

    Lima, LIMA 01

Other trials in Peru

South Korea5 sites

  • Korea University Ansan Hospital ( Site 0952)

    Ansan-si, Kyonggi-do, 15355

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

    Seoul, 03312

  • Severance Hospital ( Site 0953)

    Seoul, 03722

  • Hallym University Kangnam Sacred Heart Hospital ( Site 0951)

    Seoul, 07441

  • Korea University Guro Hospital ( Site 0950)

    Seoul, 08308

Other trials in South Korea

Czechia4 sites

  • Centrum ambulantni gynekologie a primarni pece ( Site 0401)

    Brno, Brno-mesto, 602 00

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

    Olomouc, 772 00

  • MediStar s.r.o. ( Site 0403)

    Prague, 120 00

  • FN Motol ( Site 0402)

    Prague, 150 06

Other trials in Czechia

Germany4 sites

  • Epimed GmbH ( Site 0450)

    Berlin, 10787

  • Klinische Forschung Berlin ( Site 0454)

    Berlin, 10787

  • Infektiologikum Frankfurt-Sachsenhausen ( Site 0456)

    Frankfurt am Main, Hesse, 60596

  • Universitatsklinikum Hamburg-Eppendorf ( Site 0451)

    Hamburg, 20246

Other trials in Germany

Israel4 sites

  • Rambam Medical Center ( Site 0601)

    Haifa, 3525408

  • Hadassah Medical Center. Ein Kerem ( Site 0600)

    Jerusalem, 9112001

  • Meir Medical Center ( Site 0602)

    Kfar Saba, Central District, 4428164

  • Maccabi Health Services Medical Center ( Site 0604)

    Tel Aviv, Central District, 6789140

Other trials in Israel

Mexico4 sites

  • Icaro Investigaciones en Medicina S.A. de C.V. ( Site 0200)

    Chihuahua City, 31000

  • Instituto Nacional de Salud Publica ( Site 0202)

    Cuernavaca, Morelos, 62100

  • Arke Estudios Clinicos S.A. de C.V. ( Site 0203)

    Mexico City, Mexico City, 06700

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

    Veracruz, 91910

Other trials in Mexico

Taiwan4 sites

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1003)

    Kaohsiung City, 833

  • National Cheng Kung University Hospital ( Site 1002)

    Tainan, 70403

  • National Taiwan University Hospital ( Site 1000)

    Taipei, 100

  • Chang Gung Medical Foundation.Linkou Branch ( Site 1001)

    Taoyuan, 333

Other trials in Taiwan

Thailand4 sites

  • Armed Forces Research Institute of Medical Sciences ( Site 1051)

    Bangkok, Bangkok, 10400

  • Vaccine Trial Center Faculty of Tropical Medicine ( Site 1052)

    Bangkok, Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital ( Site 1050)

    Bangkok, Bangkok, 10700

  • Research Institute for Health Sciences ( Site 1053)

    Chiang Mai, 50200

Other trials in Thailand

Belgium3 sites

  • Universitair Ziekenhuis Gasthuisberg ( Site 0353)

    Leuven, Vlaams-Brabant, 3000

  • Femicare VZW ( Site 0350)

    Tienen, Vlaams-Brabant, 3300

  • University of Antwerp ( Site 0352)

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Brazil3 sites

  • CPCLIN ( Site 0100)

    Natal, Rio Grande do Norte, 59025-050

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

    Salvador, Estado de Bahia, 40415-006

  • Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0102)

    São Paulo, 05402-000

Other trials in Brazil

Colombia3 sites

  • Clinica de la Costa Ltda. ( Site 0152)

    Barranquilla, Atlántico, 080020

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

    Chía, Cundinamarca, 250001

  • Fundacion Centro de Investigacion Clinica CIC ( Site 0153)

    Medellín, Antioquia, 050021

Other trials in Colombia

Spain3 sites

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

    Badalona, Barcelona, 08916

  • CAP Centelles ( Site 0751)

    Centelles, Barcelona, 08540

  • ICO L Hospitalet ( Site 0754)

    L'Hospitalet de Llobregat, Barcelona, 08090

Other trials in Spain

About this study

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

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.

Being tested
9vHPV Vaccine, Placebo (Saline for Injection)
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9vHPV VaccineBiological

    Also called GARDASIL®9, V503

    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)Other

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

Study groups in NCT04199689
Study groupRoleWhat they receive
9vHPV vaccineExperimentalSingle 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Receives: Biological: 9vHPV Vaccine
PlaceboPlacebo comparatorSingle 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6
Receives: Other: Placebo (Saline for Injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection

    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.

    Measured: Up to Month 90

Secondary outcomes (8)

  1. Incidence of HPV 6/11-related 6-month Persistent Oral Infection

    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.

    Measured: Up to Month 90

  2. Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies

    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.

    Measured: 1 month postdose 3 (Month 7)

  3. Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    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.

    Measured: 1 month postdose 3 (Month 7)

  4. Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)

    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.

    Measured: Up to 5 days after any vaccination

  5. Percentage of Participants with Elevated Temperature (Fever)

    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.

    Measured: Up to 5 days after any vaccination

  6. Percentage of Participants Who Report at Least 1 Systemic AE

    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.

    Measured: Up to 15 days after any vaccination

  7. Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)

    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.

    Measured: Up to 15 days after any vaccination

  8. Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE

    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.

    Measured: Up to Month 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start27 Feb 2020
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion13 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
6,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199689
Sponsor's protocol ID
V503-049
Other IDs
V503-049, 205346, 2022-501974-21-00, U1111-1275-8682, 2019-003236-23, 2019
Status last verified
Oct 2026
First submitted
12 Dec 2019
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 41276263

  • 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.

    PubMed 34838718

  • 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.

    PubMed 34838717

  • 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.

    PubMed 34678491

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV Vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 103 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Japan, France, Italy, Peru and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection (time frame: Up to Month 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04199689, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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