Comparison · NCT00092547-8ff70712
qHPV Vaccine in Base Study vs qHPV Vaccine in Extension Study: Number of Participants Reporting SAEs From Month 18 Through Month 37
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 qHPV Vaccine in Extension Study: Number of Participants Reporting SAEs From Month 18 Through Month 37. Trial comparisons, record NCT00092547-8ff70712. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00092547-8ff70712
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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 | 0 | 0.00414 | wilson | |
| Risk in group 2 | 0.00629 | 0.00214 | 0.0183 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00629 | -0.0183 | -0.000425 | 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 fewer participant with the outcome on qHPV Vaccine in Base Study than on qHPV Vaccine in Extension Study | 159 | 54.6 | 2,350 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| 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 | 0 | 923 | OG000 |
| Group 2 | qHPV Vaccine in Extension Study | Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36. | 3 | 477 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Reporting SAEs From Month 18 Through Month 37
- Description
- Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37
- Time frame
- Month 18 to Month 37
- 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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