Trial · NCT00090220
A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
NCT00090220, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019). Trials, record NCT00090220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090220
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
- NCT number
- NCT00090220
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,819 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo
- First posted
- 2004-08-27
- Last updated
- 2017-04-21
- Results first posted
- 2010-02-01
Source ClinicalTrials.gov
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ. |
| Primary | Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine. |
| Primary | Number of Participants With Vaccine-Related SAEs After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine. |
| Primary | Number of Participants With an SAE Resulting in Death After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. |
| Primary | Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1. |
| Primary | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Primary | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6. |
| Primary | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | The four HPV types were determined by PCR testing. |
| Primary | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval. |
| Primary | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | The four HPV types were determined by PCR testing. |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7 | Incidence per 100 person-years | NUMBER |
| PRIMARY | Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up | Participants | NUMBER |
| PRIMARY | Number of Participants With Vaccine-Related SAEs After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up | Participants | NUMBER |
| PRIMARY | Number of Participants With an SAE Resulting in Death After Vaccine Administration | qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120 | Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up | Participants | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Cumulative Incidence Probability | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4 | Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study) | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8 | From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Incidence per 100 person-years | NUMBER |
| PRIMARY | Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10 | From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study | Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study. | Incidence per 100 person-years | NUMBER |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group228
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | qHPV in Base Study | 0.2 | Incidence per 100 person-years | ||
| Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer | Placebo in Base Study | 1.7 | Incidence per 100 person-years | ||
| Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | qHPV in Base Study | 0 | Participants | ||
| Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Placebo in Base Study | 0 | Participants | ||
| Number of Participants With Vaccine-Related SAEs After Vaccine Administration | qHPV in Base Study | 0 | Participants | ||
| Number of Participants With Vaccine-Related SAEs After Vaccine Administration | Placebo in Base Study | 1 | Participants | ||
| Number of Participants With an SAE Resulting in Death After Vaccine Administration | qHPV in Base Study: All Participants | 8 | Participants | ||
| Number of Participants With an SAE Resulting in Death After Vaccine Administration | Base Study: Placebo | 4 | Participants | ||
| Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | qHPV in Base Study | 0.0006 | 95% Confidence Interval 0.0001 to 0.0045 | Cumulative Incidence Probability | |
| Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4 | Placebo in Base Study | 0.0124 | 95% Confidence Interval 0.0079 to 0.0195 | Cumulative Incidence Probability |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow84
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 | 1,911 | |
| Base Study Vaccination Period | STARTED | Placebo in Base Study | 1,908 | |
| Base Study Vaccination Period | STARTED | Placebo in Base Study: EXT1 | 0 | |
| Base Study Vaccination Period | STARTED | Incomplete qHPV Regimen in Base Study: EXT1 | 0 | |
| Base Study Vaccination Period | STARTED | qHPV Vaccine in Base Study: LTFU (EXT2) | 0 | |
| Base Study Vaccination Period | STARTED | Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2) | 0 | |
| Base Study Vaccination Period | Vaccinated | qHPV Vaccine in Base Study | 1,910 | |
| Base Study Vaccination Period | Vaccinated | Placebo in Base Study | 1,907 | |
| Base Study Vaccination Period | Vaccinated | Placebo in Base Study: EXT1 | 0 | |
| Base Study Vaccination Period | Vaccinated | Incomplete qHPV Regimen in Base Study: EXT1 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events284
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 | Injection site erythema | General disorders | qHPV Vaccine: Base Study | 275 | 1,890 | 392 |
| other | Injection site erythema | General disorders | Placebo: Base Study | 200 | 1,888 | 280 |
| other | Injection site erythema | General disorders | qHPV Vaccine: EXT1 | 0 | 1,327 | 0 |
| other | Injection site erythema | General disorders | Long-term Follow-up: EXT2 | 0 | 1,336 | 0 |
| other | Injection site pain | General disorders | qHPV Vaccine: Base Study | 1,424 | 1,890 | 3,168 |
| other | Injection site pain | General disorders | Placebo: Base Study | 1,173 | 1,888 | 2,252 |
| other | Injection site pain | General disorders | qHPV Vaccine: EXT1 | 0 | 1,327 | 0 |
| other | Injection site pain | General disorders | Long-term Follow-up: EXT2 | 0 | 1,336 | 0 |
| other | Injection site swelling | General disorders | qHPV Vaccine: Base Study | 356 | 1,890 | 530 |
| other | Injection site swelling | General disorders | Placebo: Base Study | 215 | 1,888 | 293 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 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 | ||
| Total, all-cause mortality | Placebo: Base Study | ||
| Total, all-cause mortality | qHPV Vaccine: EXT1 | ||
| Total, all-cause mortality | Long-term Follow-up: EXT2 | ||
| Total, other adverse events | qHPV Vaccine: Base Study | 1,565 | 1,890 |
| Total, other adverse events | Placebo: Base Study | 1,390 | 1,888 |
| Total, other adverse events | qHPV Vaccine: EXT1 | 2 | 1,327 |
| Total, other adverse events | Long-term Follow-up: EXT2 | 0 | 1,336 |
| Total, serious adverse events | qHPV Vaccine: Base Study | 15 | 1,890 |
| Total, serious adverse events | Placebo: Base Study | 17 | 1,888 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| qHPV in Base Study vs Placebo in Base Study: Number of Participants With Vaccine-Related SAEs After Vaccine Administration | Trial comparisons |
| qHPV in Base Study vs Placebo in Base Study: Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study | Trial comparisons |
| qHPV in Base Study: All Participants vs Base Study: Placebo: Number of Participants With an SAE Resulting in Death After Vaccine Administration | 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/NCT00090220
GET https://conductscience.org/api/trials/v1/NCT00090220/registered?page=2