Comparison · NCT00090285-87635799
qHPV Vaccine in Base Study vs Placebo in Base Study: Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. qHPV Vaccine in Base Study vs Placebo in Base Study: Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs). Trial comparisons, record NCT00090285-87635799. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090285-87635799
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0124 | 0.0084 | 0.0182 | wilson | |
| Risk in group 2 | 0.00986 | 0.00639 | 0.0152 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00252 | -0.00412 | 0.0093 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.7 | 2.25 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.697 | 2.27 | log | |
| Number needed to treat, for one more participant with the outcome on qHPV Vaccine in Base Study than on Placebo in Base Study | 397 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | qHPV Vaccine in Base Study | 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. | 25 | 2,020 | OG000 |
| Group 2 | Placebo in Base Study | 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. | 20 | 2,029 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
- Description
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.
- Time frame
- Base study: through Day 5 after any vaccination
- Population
- The analysis population included all vaccinated participants excluding 6 participants who received non-compliant mixed regimens of qHPV vaccine and placebo.
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
- NCT number
- NCT00090285
- Phases
- PHASE3
- Conditions
- Condylomata Acuminata
- Interventions
- (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Comparator: placebo (unspecified)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2009-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090285?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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