Comparison · NCT00092547-08f63ff4
qHPV Vaccine in Base Study vs Placebo in Base Study: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. qHPV Vaccine in Base Study vs Placebo in Base Study: Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18. Trial comparisons, record NCT00092547-08f63ff4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00092547-08f63ff4
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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 | 0.00515 | 0.00236 | 0.0112 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00653 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00515 | -0.00195 | 0.0112 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on qHPV Vaccine in Base Study than on Placebo in Base Study | 194 | 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 | Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6 | 6 | 1,165 | OG000 |
| Group 2 | Placebo in Base Study | Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6 | 0 | 584 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18
- Description
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.
- Time frame
- Up to Month 18
- Population
- All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
- NCT number
- NCT00092547
- Phases
- PHASE3
- Conditions
- Human, Papillomavirus Infections
- Interventions
- V501, Comparator: Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2010-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00092547?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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