Trial · NCT00834106
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
NCT00834106, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2017-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041). Trials, record NCT00834106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00834106
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
- NCT number
- NCT00834106
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,006 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- HPV Infections
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: placebo (unspecified)
- First posted
- 2009-02-03
- Last updated
- 2019-02-04
- Results first posted
- 2017-10-12
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | From Day 1 until >=25 cases accumulate, up to Month 30 | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block. |
| Primary | Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | From Day 1 until >=17 cases accumulate, up to Month 30 | The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. |
| Primary | Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | Up to Month 78 | The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block. |
| Primary | Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | Up to 15 days after any vaccination | An adverse event (AE) 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 AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination. |
| Primary | Base Study: Percentage of Participants With One or More Systemic Adverse Events | Up to 15 days after any vaccination | An AE 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 AE. |
| Primary | Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event | Up to 6 months | An AE 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 AE. |
| Primary | Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events | Up to approximately 90 months | 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 an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure. |
| Primary | Entire Study: Percentage of Participants Who Died | Up to approximately 90 months | The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm |
| Secondary | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update) | Up to 78 months | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. |
| Secondary | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update) | Up to 78 months | The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | From Day 1 until >=25 cases accumulate, up to Month 30 | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Cases per 100 person-years of follow-up | NUMBER |
| PRIMARY | Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | From Day 1 until >=17 cases accumulate, up to Month 30 | The population analyzed included participants 20 to 26 years old at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Cases per 100 person-years of follow-up | NUMBER |
| PRIMARY | Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | Up to Month 78 | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 16 and 18. | Cases per 100 person-years of follow-up | NUMBER |
| PRIMARY | Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | Up to 15 days after any vaccination | All vaccinated participants with safety follow-up | Percentage of participants | NUMBER |
| PRIMARY | Base Study: Percentage of Participants With One or More Systemic Adverse Events | Up to 15 days after any vaccination | All vaccinated participants with safety follow-up | Percentage of participants | NUMBER |
| PRIMARY | Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event | Up to 6 months | All vaccinated participants with safety follow-up | Percentage of participants | NUMBER |
| PRIMARY | Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events | Up to approximately 90 months | All vaccinated participants with safety follow-up | Percentage of participants | NUMBER |
| PRIMARY | Entire Study: Percentage of Participants Who Died | Up to approximately 90 months | All vaccinated participants with safety follow-up | Percentage of participants | NUMBER |
| SECONDARY | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update) | Up to 78 months | The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Cases per 100 person-years of follow-up | NUMBER |
| SECONDARY | Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update) | Up to 78 months | The population analyzed included participants 20 to 26 years of age at Baseline who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for HPV types 6, 11, 16, and 18. | Cases per 100 person-years of follow-up | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | qHPV | 0.3 | Cases per 100 person-years of follow-up | ||
Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) | Placebo | 1.2 | Cases per 100 person-years of follow-up | ||
Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | qHPV | 0.2 | Cases per 100 person-years of follow-up | ||
Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis) | Placebo | 1.2 | Cases per 100 person-years of follow-up | ||
| Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | qHPV | 0.0 | Cases per 100 person-years of follow-up | ||
| Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis) | Placebo | 0.1 | Cases per 100 person-years of follow-up | ||
| Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | qHPV | 37.6 | Percentage of participants | ||
| Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events | Placebo | 27.8 | Percentage of participants | ||
| Base Study: Percentage of Participants With One or More Systemic Adverse Events | qHPV | 50.4 | Percentage of participants | ||
| Base Study: Percentage of Participants With One or More Systemic Adverse Events | Placebo | 48.7 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study (Day 1 to Month 30) | STARTED | qHPV | 1,503 | |
| Base Study (Day 1 to Month 30) | STARTED | Placebo | 1,503 | |
| Base Study (Day 1 to Month 30) | Vaccinated | qHPV | 1,503 | |
| Base Study (Day 1 to Month 30) | Vaccinated | Placebo | 1,503 | |
| Base Study (Day 1 to Month 30) | Completed Vaccinations | qHPV | 1,473 | |
| Base Study (Day 1 to Month 30) | Completed Vaccinations | Placebo | 1,463 | |
| Base Study (Day 1 to Month 30) | COMPLETED | qHPV | 1,401 | |
| Base Study (Day 1 to Month 30) | COMPLETED | Placebo | 1,358 | |
| Base Study (Day 1 to Month 30) | NOT COMPLETED | qHPV | 102 | |
| Base Study (Day 1 to Month 30) | NOT COMPLETED | Placebo | 145 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events150
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 | Diarrhoea | Gastrointestinal disorders | qHPV | 89 | 1,499 | 106 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 94 | 1,498 | 105 |
| other | Nausea | Gastrointestinal disorders | qHPV | 100 | 1,499 | 122 |
| other | Nausea | Gastrointestinal disorders | Placebo | 95 | 1,498 | 106 |
| other | Fatigue | General disorders | qHPV | 227 | 1,499 | 310 |
| other | Fatigue | General disorders | Placebo | 193 | 1,498 | 247 |
| other | Injection Site Erythema | General disorders | qHPV | 176 | 1,499 | 233 |
| other | Injection Site Erythema | General disorders | Placebo | 133 | 1,498 | 163 |
| other | Injection Site Induration | General disorders | qHPV | 115 | 1,499 | 151 |
| other | Injection Site Induration | General disorders | Placebo | 64 | 1,498 | 76 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | qHPV | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | qHPV | 876 | 1,499 |
| Total, other adverse events | Placebo | 799 | 1,498 |
| Total, serious adverse events | qHPV | 38 | 1,499 |
| Total, serious adverse events | Placebo | 43 | 1,498 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| qHPV vs Placebo: serious adverse events |
Source 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/NCT00834106
GET https://conductscience.org/api/trials/v1/NCT00834106/events?page=2