Condylomata AcuminataPhase 3NCT00090285

An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

A Phase 3 study testing (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in people with Condylomata Acuminata, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 26 years, men onlyHealthy volunteers can take part
Conditions the study is for: Condylomata Acuminata
What is being tested?: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,065 participants
Where: No sites listed yet
Study dates: 3 Sep 2004to 3 Apr 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 26 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
Additional criteria will be discussed with you by the physician

Who cannot join

Concurrently enrolled in a clinical study involving collection of genital specimens
History of known prior vaccination with an HPV vaccine
Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
History of a severe allergic reaction that required medical intervention
Received any immune globulin or blood-derived products within 6 months prior to the first study injection
History of splenectomy, immune disorders, or receiving immunosuppressives

Show all 9Show fewer

Immunocompromised or diagnosed with HIV infection
Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
History of recent or ongoing alcohol or drug abuse

About this study

Official title: An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus [qHPV] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 [LTFU (EXT2)], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).

Conditions: Condylomata Acuminata
Being tested: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Comparator: placebo (unspecified)
Keywords: anogenital warts
Medical subject headings: Condylomata Acuminata

What participants receive

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

(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccineBiological
Also called qHPV, V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
Comparator: placebo (unspecified)Biological
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Study groups in NCT00090285
Study group	Role	What they receive
qHPV Vaccine	Experimental	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36. Receives: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Placebo	Placebo comparator	The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36. Receives: Biological: Comparator: placebo (unspecified)

What is being measured

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

Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Measured: Base study: through Month 36
Overall Study: Incidence of HPV Type 6/11-related Genital Warts
Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Measured: Up to 10 years after the first dose of qHPV vaccine
Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Measured: Up to 10 years after the first dose of qHPV vaccine
Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
Measured: Up to 10 years after the first dose of qHPV vaccine
Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
Measured: Base study: through Day 5 after any vaccination
Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Measured: Base study: through Month 36
LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
Measured: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
LTFU (EXT2): Number of Participants Who Died
The number of participants who died was assessed.
Measured: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine

Secondary outcomes (12)

Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed.
Measured: Base study: through Month 36
Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed.
Measured: Base study: through Month 36
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Measured: Month 7
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Measured: Month 36
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Measured: Month 72
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Antibody titers were expressed as cLIA milli Merck units/mL (cLIA mMU/mL).
Measured: Month 120
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Measured: Month 7
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Measured: Month 36
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Measured: Month 72
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Antibodies to HPV types were measured using cLIA. Thresholds for seropositive were ≥20, 16, 20, and 24 cLIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Measured: Month 120
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Antibodies to HPV types were measured using Luminex immunoassay (IgG-LIA). The unit of measure for this assay is IgG LIA mMU/mL; this unit cannot be directly compared with the cLIA mMU/mL unit reported for the cLIA results.
Measured: Month 120
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
Antibodies to HPV types were measured using IgG LIA. Thresholds for seropositive were ≥9, 6, 5, and 5 IgG LIA mMU/mL for HPV Types 6, 11, 16, and 18, respectively.
Measured: Month 120

Timeline

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

3 Sep 20043 Apr 2017

First posted27 Aug 2004 (estimated)
Study start3 Sep 2004
Primary completion31 Jul 2009
Study completion3 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Condylomata AcuminataStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 4,065 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00090285
Sponsor's protocol ID: V501-020
Other IDs: Formerly-0904HPVHMES, 2004_103, 2004-002945-10, V501-020, 2004
Status last verified: Jul 2018
First submitted: 25 Aug 2004
Last updated: 23 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

Publications

Broshkevitch CJ, Giuliano AR, Palefsky JM, Nahhas G, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Assessment of Concordant Human Papillomavirus Infection With 9-Valent Vaccine Types Across Anogenital Sites in Young Men. J Infect Dis. 2026 Feb 18;233(2):e462-e470. doi: 10.1093/infdis/jiaf564.
PubMed 41400842
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
Palefsky JM, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men. Clin Infect Dis. 2026 Mar 17;82(3):e616-e625. doi: 10.1093/cid/ciaf584.
PubMed 41162330
Giuliano AR, Palefsky JM, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men. J Infect Dis. 2024 Mar 14;229(3):707-718. doi: 10.1093/infdis/jiad485.
PubMed 38012959
Goldstone SE, Giuliano AR, Palefsky JM, Lazcano-Ponce E, Penny ME, Cabello RE, Moreira ED Jr, Baraldi E, Jessen H, Ferenczy A, Kurman R, Ronnett BM, Stoler MH, Bautista O, Das R, Group T, Luxembourg A, Zhou HJ, Saah A. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Mar;22(3):413-425. doi: 10.1016/S1473-3099(21)00327-3. Epub 2021 Nov 12.
PubMed 34780705
Tota JE, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Palefsky JM. Anogenital Human Papillomavirus (HPV) Infection, Seroprevalence, and Risk Factors for HPV Seropositivity Among Sexually Active Men Enrolled in a Global HPV Vaccine Trial. Clin Infect Dis. 2022 Apr 9;74(7):1247-1256. doi: 10.1093/cid/ciab603.
PubMed 34265048
Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.
PubMed 32184277
Goldstone SE, Jessen H, Palefsky JM, Giuliano AR, Moreira ED Jr, Vardas E, Aranda C, Hillman RJ, Ferris DG, Coutlee F, Marshall JB, Vuocolo S, Haupt RM, Guris D, Garner E. Quadrivalent HPV vaccine efficacy against disease related to vaccine and non-vaccine HPV types in males. Vaccine. 2013 Aug 20;31(37):3849-55. doi: 10.1016/j.vaccine.2013.06.057. Epub 2013 Jul 2.
PubMed 23831322
Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen H, Hillman R, Ferris D, Coutlee F, Stoler MH, Marshall JB, Radley D, Vuocolo S, Haupt RM, Guris D, Garner EI. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011 Oct 27;365(17):1576-85. doi: 10.1056/NEJMoa1010971.
PubMed 22029979
Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, Chang YH, Ferris D, Rouleau D, Bryan J, Marshall JB, Vuocolo S, Barr E, Radley D, Haupt RM, Guris D. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. doi: 10.1056/NEJMoa0909537.
PubMed 21288094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital Warts
RecruitingObservational study
Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
Psoriasis, Condyloma Acuminata
RecruitingPhase 2
To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years
HPV Infection, HPV-Related Carcinoma
Active, not recruitingPhase 3
Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Cervical Intraepithelial Neoplasia, Cervical Cancer

All Condylomata Acuminata trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
ClinicalTrials.gov ID: NCT00090285
Acronym / sponsor ID: V501-020
Conditions: Condylomata Acuminata
Keywords: anogenital warts
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,065 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Sep 2004 (actual)
Primary completion: 31 Jul 2009 (actual)
Study completion: 3 Apr 2017 (actual)
First posted: 27 Aug 2004 (estimated)
Results: Posted 19 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
qHPV Vaccine	Experimental	Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccineThe Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.
Placebo	Placebo comparator	Biological: Comparator: placebo (unspecified)The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.

Who may qualify

Ages: 16 to 26 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
Additional criteria will be discussed with you by the physician

Key exclusion criteria (9 listed)

Concurrently enrolled in a clinical study involving collection of genital specimens
History of known prior vaccination with an HPV vaccine
Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
History of a severe allergic reaction that required medical intervention
Received any immune globulin or blood-derived products within 6 months prior to the first study injection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccineAlso: qHPV, V5010.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study	Biological	qHPV Vaccine
Comparator: placebo (unspecified)0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study	Biological	Placebo

Primary outcome

Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
Time frame: Base study: through Month 36
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Overall Study: Incidence of HPV Type 6/11-related Genital Warts
Time frame: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
Time frame: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
Time frame: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
Time frame: Base study: through Day 5 after any vaccination
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Time frame: Base study: through Month 36
A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
Time frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
LTFU (EXT2): Number of Participants Who Died
Time frame: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
The number of participants who died was assessed.

12 secondary outcomes

Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection
Time frame: Base study: through Month 36
Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
Time frame: Base study: through Month 36
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)
Time frame: Month 7
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Time frame: Month 36
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Time frame: Month 72
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Time frame: Month 120
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA
Time frame: Month 7
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA
Time frame: Month 36
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA
Time frame: Month 72
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA
Time frame: Month 120
Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)
Time frame: Month 120
Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA
Time frame: Month 120

Results and safety

Results posted to the registry on 19 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
qHPV Vaccine in Base Study	2,032	1,818
Placebo in Base Study	2,033	1,814
EXT1: Placebo in Base Study	0	0
EXT1: Incomplete qHPV Regimen in Base Study	0	0
LTFU (EXT2): Early Vaccination Group	0	0
LTFU (EXT2): Catch-up Vaccination Group	0	0

Primary outcome: Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer

Time frame: Base study: through Month 36. Number. Unit: Incidence per 100 person-years

Measure	qHPV Vaccine in Base Study n = 1394	Placebo in Base Study n = 1404
Value	0.1	1.0

qHPV Vaccine in Base Study vs Placebo in Base Study: Risk Difference (RD): 90.6 (95% CI 70.1 to 98.2)

Population analysed: Participants must have received 3 doses of qHPV vaccine or placebo, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7.

Primary outcome: Overall Study: Incidence of HPV Type 6/11-related Genital Warts

Time frame: Up to 10 years after the first dose of qHPV vaccine. Number (95% Confidence Interval). Unit: Incidence per 10,000 person-years

Measure	qHPV Vaccine in Base Study n = 1243
Value	4.3 (0.9 to 12.5)

Population analysed: Participants must have received 3 doses of qHPV vaccine, have no protocol violations that could interfere with the effects of the vaccine, be seronegative at Day 1 and PCR negative Day 1 through Month 7 for the relevant HPV type, and must provide data after Month 7. This endpoint applied only to participants in the Base Study qHPV vaccine group.

Primary outcome: Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer

Time frame: Up to 10 years after the first dose of qHPV vaccine. Number (95% Confidence Interval). Unit: Incidence per 10,000 person-years

Measure	qHPV Vaccine in Base Study n = 1395
Value	3.8 (0.8 to 11.1)

Primary outcome: Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer

Time frame: Up to 10 years after the first dose of qHPV vaccine. Number (95% Confidence Interval). Unit: Incidence per 10,000 person-years

Measure	MSM qHPV Vaccine in Base Study n = 194
Value	69.3 (25.4 to 150.8)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Base study: all AEs were collected systematically from Day 1 through Month 36. EXT 1: SAEs were collected systematically from Day 1 through Month 7. LTFU (EXT2): deaths and vaccine-related SAEs were collected up to 12 years after last dose of qHPV vaccine in Early Vaccination Group and up to 7 years after last dose of qHPV in Catch-up Vaccination Group.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
qHPV Vaccine: Base Study	8 of 2,020 (0.4%)	1,277 of 2,020 (63.2%)	3 of 2,020
Placebo: Base Study	11 of 2,029 (0.5%)	1,183 of 2,029 (58.3%)	10 of 2,029
qHPV Vaccine: EXT1	3 of 1,084 (0.3%)	0 of 0	2 of 1,084
LTFU (EXT2)	7 of 1,803 (0.4%)	0 of 0	7 of 1,803

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41400842Broshkevitch CJ, Giuliano AR, Palefsky JM, Nahhas G, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Assessment of Concordant Human Papillomavirus Infection With 9-Valent Vaccine Types Across Anogenital Sites in Young Men. J Infect Dis. 2026 Feb 18;233(2):e462-e470. doi: 10.1093/infdis/jiaf564.
Derived from this study: PubMed 41276263Bergman 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.
Derived from this study: PubMed 41162330Palefsky JM, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. Anal Human Papillomavirus Infection Progression to Disease Among Men Who Have Sex With Men. Clin Infect Dis. 2026 Mar 17;82(3):e616-e625. doi: 10.1093/cid/ciaf584.
Derived from this study: PubMed 38012959Giuliano AR, Palefsky JM, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Tota JE. High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men. J Infect Dis. 2024 Mar 14;229(3):707-718. doi: 10.1093/infdis/jiad485.
Derived from this study: PubMed 34780705Goldstone SE, Giuliano AR, Palefsky JM, Lazcano-Ponce E, Penny ME, Cabello RE, Moreira ED Jr, Baraldi E, Jessen H, Ferenczy A, Kurman R, Ronnett BM, Stoler MH, Bautista O, Das R, Group T, Luxembourg A, Zhou HJ, Saah A. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Mar;22(3):413-425. doi: 10.1016/S1473-3099(21)00327-3. Epub 2021 Nov 12.
Derived from this study: PubMed 34265048Tota JE, Giuliano AR, Goldstone SE, Dubin B, Saah A, Luxembourg A, Velicer C, Palefsky JM. Anogenital Human Papillomavirus (HPV) Infection, Seroprevalence, and Risk Factors for HPV Seropositivity Among Sexually Active Men Enrolled in a Global HPV Vaccine Trial. Clin Infect Dis. 2022 Apr 9;74(7):1247-1256. doi: 10.1093/cid/ciab603.
Derived from this study: PubMed 32184277Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.
Derived from this study: PubMed 23831322Goldstone SE, Jessen H, Palefsky JM, Giuliano AR, Moreira ED Jr, Vardas E, Aranda C, Hillman RJ, Ferris DG, Coutlee F, Marshall JB, Vuocolo S, Haupt RM, Guris D, Garner E. Quadrivalent HPV vaccine efficacy against disease related to vaccine and non-vaccine HPV types in males. Vaccine. 2013 Aug 20;31(37):3849-55. doi: 10.1016/j.vaccine.2013.06.057. Epub 2013 Jul 2.
Derived from this study: PubMed 22029979Palefsky JM, Giuliano AR, Goldstone S, Moreira ED Jr, Aranda C, Jessen H, Hillman R, Ferris D, Coutlee F, Stoler MH, Marshall JB, Radley D, Vuocolo S, Haupt RM, Guris D, Garner EI. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011 Oct 27;365(17):1576-85. doi: 10.1056/NEJMoa1010971.
Derived from this study: PubMed 21288094Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, Vardas E, Moi H, Jessen H, Hillman R, Chang YH, Ferris D, Rouleau D, Bryan J, Marshall JB, Vuocolo S, Barr E, Radley D, Haupt RM, Guris D. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. doi: 10.1056/NEJMoa0909537.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in people with Condylomata Acuminata, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer (time frame: Base study: through Month 36). The study lists 8 primary outcomes in all. 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 NCT00090285, which also lists 10 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 23 Aug 2018.