Comparison · NCT00090220-fa51956a
qHPV in Base Study: All Participants vs Base Study: Placebo: Number of Participants With an SAE Resulting in Death After Vaccine Administration
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 in Base Study: All Participants vs Base Study: Placebo: Number of Participants With an SAE Resulting in Death After Vaccine Administration. Trial comparisons, record NCT00090220-fa51956a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090220-fa51956a
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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 | 0.00423 | 0.00215 | 0.00833 | wilson | |
| Risk in group 2 | 0.00301 | 0.00117 | 0.00772 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00122 | -0.00393 | 0.00571 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.424 | 4.65 | log | |
| Odds ratio, group 1 over group 2 | 1.41 | 0.422 | 4.68 | log | |
| Number needed to treat, for one more participant with the outcome on qHPV in Base Study: All Participants than on Base Study: Placebo | 821 | 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 in Base Study: All Participants | Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study | 8 | 1,890 | OG000 |
| Group 2 | Base Study: Placebo | Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1 | 4 | 1,327 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With an SAE Resulting in Death After Vaccine Administration
- Description
An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. 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 a cancer, or is an overdose.
- Time frame
- qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120
- Population
- Participants who received \>=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)
- NCT number
- NCT00090220
- Phases
- PHASE3
- Conditions
- Healthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2010-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090220?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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