Trial · NCT00092547
A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
NCT00092547, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2010-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018). Trials, record NCT00092547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00092547
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
- NCT number
- NCT00092547
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,781 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Human, Papillomavirus Infections
- Interventions
- V501, Comparator: Placebo
- First posted
- 2004-09-28
- Last updated
- 2018-02-20
- Results first posted
- 2010-05-04
- Limitations and caveats
The difference between the prior and final data is a minor change in the definition of the per-protocol immunogenicity population, which was applied down to the base study. Also, protocol violators were identified and excluded from the analysis.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | Up to Month 18 | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. |
| Primary | Number of Participants Reporting SAEs From Month 18 Through Month 37 | Month 18 to Month 37 | Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37 |
| Primary | Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination | Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18 |
| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | |
| Primary | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group) | |
| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Primary | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | |
| Primary | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18. |
| Primary | Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | Month 37 to Month 126 | A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | Up to Month 18 | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting SAEs From Month 18 Through Month 37 | Month 18 to Month 37 | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination | All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up. | participants | NUMBER |
| PRIMARY | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Percentage of participants | NUMBER |
| PRIMARY | Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72 | Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group) | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | milliMerck units/mL | GEOMETRIC_MEAN |
| PRIMARY | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group) | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | milliMerck units/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96 | Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Percentage of participants | NUMBER |
| PRIMARY | Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | milliMerck units/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126 | Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group) | Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | Month 37 to Month 126 | The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up. | Participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | qHPV Vaccine in Base Study | 6 | participants | ||
| Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | Placebo in Base Study | 0 | participants | ||
| Number of Participants Reporting SAEs From Month 18 Through Month 37 | qHPV Vaccine in Base Study | 0 | participants | ||
| Number of Participants Reporting SAEs From Month 18 Through Month 37 | qHPV Vaccine in Extension Study | 3 | participants | ||
| Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | qHPV Vaccine in Base Study | 918 | participants | ||
| Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Placebo in Base Study | 340 | participants | ||
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | qHPV Vaccine in Base Study | Type 6: n=475, 151 | 93.3 | 95% Confidence Interval 90.6 to 95.3 | Percentage of participants |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | qHPV Vaccine in Extension Study | Type 6: n=475, 151 | 91.4 | 95% Confidence Interval 85.7 to 95.3 | Percentage of participants |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | qHPV Vaccine in Base Study | Type 11: n=475, 151 | 96.0 | 95% Confidence Interval 93.8 to 97.6 | Percentage of participants |
| Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72 | qHPV Vaccine in Extension Study | Type 11: n=475, 151 | 96.7 | 95% Confidence Interval 92.4 to 98.9 | Percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Vaccine Phase (Day 1 to Month 7) | STARTED | qHPV Vaccine in Base Study | 1,184 | |
| Base Vaccine Phase (Day 1 to Month 7) | STARTED | Placebo in Base Study | 597 | |
| Base Vaccine Phase (Day 1 to Month 7) | STARTED | qHPV Vaccine in Extension Study | 0 | |
| Base Vaccine Phase (Day 1 to Month 7) | Vaccinated | qHPV Vaccine in Base Study | 1,179 | |
| Base Vaccine Phase (Day 1 to Month 7) | Vaccinated | Placebo in Base Study | 596 | |
| Base Vaccine Phase (Day 1 to Month 7) | Vaccinated | qHPV Vaccine in Extension Study | 0 | |
| Base Vaccine Phase (Day 1 to Month 7) | COMPLETED | qHPV Vaccine in Base Study | 1,121 | |
| Base Vaccine Phase (Day 1 to Month 7) | COMPLETED | Placebo in Base Study | 561 | |
| Base Vaccine Phase (Day 1 to Month 7) | COMPLETED | qHPV Vaccine in Extension Study | 0 | |
| Base Vaccine Phase (Day 1 to Month 7) | NOT COMPLETED | qHPV Vaccine in Base Study | 63 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events76
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 in Base: Vaccine Phase and Follow-up | 237 | 1,165 | 323 |
| other | Injection site erythema | General disorders | Placebo in Base: Vaccine Phase and Follow-up | 78 | 584 | 109 |
| other | Injection site erythema | General disorders | qHPV Vaccine in Base: Extension and Long-term Follow-up | 0 | 932 | 0 |
| other | Injection site erythema | General disorders | qHPV Vaccine in Extension: Extension and Long-term Follow-up | 1 | 481 | 1 |
| other | Injection site pain | General disorders | qHPV Vaccine in Base: Vaccine Phase and Follow-up | 853 | 1,165 | 1,705 |
| other | Injection site pain | General disorders | Placebo in Base: Vaccine Phase and Follow-up | 268 | 584 | 434 |
| other | Injection site pain | General disorders | qHPV Vaccine in Base: Extension and Long-term Follow-up | 0 | 932 | 0 |
| other | Injection site pain | General disorders | qHPV Vaccine in Extension: Extension and Long-term Follow-up | 3 | 481 | 3 |
| other | Injection site swelling | General disorders | qHPV Vaccine in Base: Vaccine Phase and Follow-up | 241 | 1,165 | 336 |
| other | Injection site swelling | General disorders | Placebo in Base: Vaccine Phase and Follow-up | 45 | 584 | 63 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | qHPV Vaccine in Base: Vaccine Phase and Follow-up | ||
| Total, all-cause mortality | Placebo in Base: Vaccine Phase and Follow-up | ||
| Total, all-cause mortality | qHPV Vaccine in Base: Extension and Long-term Follow-up | ||
| Total, all-cause mortality | qHPV Vaccine in Extension: Extension and Long-term Follow-up | ||
| Total, other adverse events | qHPV Vaccine in Base: Vaccine Phase and Follow-up | 918 | 1,165 |
| Total, other adverse events | Placebo in Base: Vaccine Phase and Follow-up | 344 | 584 |
| Total, other adverse events | qHPV Vaccine in Base: Extension and Long-term Follow-up | 0 | 932 |
| Total, other adverse events | qHPV Vaccine in Extension: Extension and Long-term Follow-up | 3 | 481 |
| Total, serious adverse events | qHPV Vaccine in Base: Vaccine Phase and Follow-up | 6 | 1,165 |
| Total, serious adverse events | Placebo in Base: Vaccine Phase and Follow-up | 0 | 584 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
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 |
|---|---|
| qHPV Vaccine in Base Study vs Placebo in Base Study: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18 | Trial comparisons |
| qHPV Vaccine in Base Study vs qHPV Vaccine in Extension Study: Number of Participants Reporting SAEs From Month 18 Through Month 37 | Trial comparisons |
| qHPV Vaccine in Base Study vs Placebo in Base Study: Number of Participants Reporting Other (Non-serious) AEs Through Month 18 | Trial comparisons |
| qHPV Vaccine in Base Study vs qHPV Vaccine in Extension Study: Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up | 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/NCT00092547
GET https://conductscience.org/api/trials/v1/NCT00092547/registered?page=2