Trial · NCT00090285
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
NCT00090285, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020). Trials, record NCT00090285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090285
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
- NCT number
- NCT00090285
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,065 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Condylomata Acuminata
- Interventions
- (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Comparator: placebo (unspecified)
- First posted
- 2004-08-27
- Last updated
- 2018-08-23
- Other registries' IDs
- eudract:2004-002945-10
- Results first posted
- 2009-11-19
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Primary | Overall Study: Incidence of HPV Type 6/11-related Genital Warts | 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. |
| Primary | Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer | 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. |
| Primary | Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer | 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. |
| Primary | Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) | 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. |
| Primary | Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) | 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. |
| Primary | LTFU (EXT2): Number of Participants With Vaccine-Related SAEs | 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. |
| Primary | LTFU (EXT2): Number of Participants Who Died | 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. |
| Secondary | Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection | Base study: through Month 36 | Participants with HPV Type 6/11/16/18-related persistent infection per 100 person-years of follow-up was assessed. |
| Secondary | Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection | Base study: through Month 36 | Participants with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up was assessed. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Base study: through Month 36 | 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. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Overall Study: Incidence of HPV Type 6/11-related Genital Warts | Up to 10 years after the first dose of qHPV vaccine | 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. | Incidence per 10,000 person-years | NUMBER |
| PRIMARY | Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer | Up to 10 years after the first dose of qHPV vaccine | 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. | Incidence per 10,000 person-years | NUMBER |
| PRIMARY | Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer | Up to 10 years after the first dose of qHPV vaccine | 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 MSM in the Base Study qHPV vaccine group. | Incidence per 10,000 person-years | NUMBER |
| PRIMARY | Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) | Base study: through Day 5 after any vaccination | The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) | Base study: through Month 36 | The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | LTFU (EXT2): Number of Participants With Vaccine-Related SAEs | 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 population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | LTFU (EXT2): Number of Participants Who Died | 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 population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Base Study: Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM) | Base study: through Month 36 | Only a subset of participants was included for this sub-study. 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. | Incidence per 100 person-years | NUMBER |
| SECONDARY | Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection | Base study: through Month 36 | 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. | Infection per 100 person-years | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | qHPV Vaccine in Base Study | 0.1 | Incidence per 100 person-years | ||
| 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 | Placebo in Base Study | 1.0 | Incidence per 100 person-years | ||
| Overall Study: Incidence of HPV Type 6/11-related Genital Warts | qHPV Vaccine in Base Study | 4.3 | 95% Confidence Interval 0.9 to 12.5 | Incidence per 10,000 person-years | |
| Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer | qHPV Vaccine in Base Study | 3.8 | 95% Confidence Interval 0.8 to 11.1 | Incidence per 10,000 person-years | |
| Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer | MSM qHPV Vaccine in Base Study | 69.3 | 95% Confidence Interval 25.4 to 150.8 | Incidence per 10,000 person-years | |
| Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) | qHPV Vaccine in Base Study | 25 | Participants | ||
| Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) | Placebo in Base Study | 20 | Participants | ||
| Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) | qHPV Vaccine: Base Study and Followup | 0 | Participants | ||
| Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) | Placebo: Base Study and Followup | 0 | Participants | ||
| LTFU (EXT2): Number of Participants With Vaccine-Related SAEs | LTFU (EXT2): Early Vaccination Group | 0 | Participants |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study Vaccination Period | STARTED | qHPV Vaccine in Base Study | 2,032 | |
| Base Study Vaccination Period | STARTED | Placebo in Base Study | 2,033 | |
| Base Study Vaccination Period | STARTED | EXT1: Placebo in Base Study | 0 | |
| Base Study Vaccination Period | STARTED | EXT1: Incomplete qHPV Regimen in Base Study | 0 | |
| Base Study Vaccination Period | STARTED | LTFU (EXT2): Early Vaccination Group | 0 | |
| Base Study Vaccination Period | STARTED | LTFU (EXT2): Catch-up Vaccination Group | 0 | |
| Base Study Vaccination Period | Vaccinated | qHPV Vaccine in Base Study | 2,025 | |
| Base Study Vaccination Period | Vaccinated | Placebo in Base Study | 2,030 | |
| Base Study Vaccination Period | Vaccinated | EXT1: Placebo in Base Study | 0 | |
| Base Study Vaccination Period | Vaccinated | EXT1: Incomplete qHPV Regimen in Base Study | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events176
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | qHPV Vaccine: Base Study | 19 | 2,020 | 21 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo: Base Study | 23 | 2,029 | 23 |
| other | Abdominal pain upper | Gastrointestinal disorders | qHPV Vaccine: EXT1 | 0 | 0 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | LTFU (EXT2) | 0 | 0 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | qHPV Vaccine: Base Study | 40 | 2,020 | 44 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Base Study | 36 | 2,029 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | qHPV Vaccine: EXT1 | 0 | 0 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | LTFU (EXT2) | 0 | 0 | 0 |
| other | Nausea | Gastrointestinal disorders | qHPV Vaccine: Base Study | 27 | 2,020 | 30 |
| other | Nausea | Gastrointestinal disorders | Placebo: Base Study | 16 | 2,029 | 16 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | qHPV Vaccine: Base Study | 3 | 2,020 |
| Total, all-cause mortality | Placebo: Base Study | 10 | 2,029 |
| Total, all-cause mortality | qHPV Vaccine: EXT1 | 2 | 1,084 |
| Total, all-cause mortality | LTFU (EXT2) | 7 | 1,803 |
| Total, other adverse events | qHPV Vaccine: Base Study | 1,277 | 2,020 |
| Total, other adverse events | Placebo: Base Study | 1,183 | 2,029 |
| Total, other adverse events | qHPV Vaccine: EXT1 | 0 | 0 |
| Total, other adverse events | LTFU (EXT2) | 0 | 0 |
| Total, serious adverse events | qHPV Vaccine: Base Study | 8 | 2,020 |
| Total, serious adverse events | Placebo: Base Study | 11 | 2,029 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LTFU (EXT2): Early Vaccination Group vs LTFU (EXT2): Catch-up Vaccination Group: LTFU (EXT2): Number of Participants With Vaccine-Related SAEs | Trial comparisons |
| qHPV Vaccine in Base Study vs Placebo in Base Study: Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs) | Trial comparisons |
| LTFU (EXT2): Early Vaccination Group vs LTFU (EXT2): Catch-up Vaccination Group: LTFU (EXT2): Number of Participants Who Died | Trial comparisons |
| qHPV Vaccine: Base Study and Followup vs Placebo: Base Study and Followup: Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00090285
GET https://conductscience.org/api/trials/v1/NCT00090285/registered?page=2