Comparison · NCT00090220-d5fcf305
qHPV in Base Study vs Placebo in Base Study: Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study
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 vs Placebo in Base Study: Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study. Trial comparisons, record NCT00090220-d5fcf305. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090220-d5fcf305
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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 | 0.00203 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00203 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00203 | 0.00203 | 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 | from the risk difference interval | the two groups' risks are equal |
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 | Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study | 0 | 1,890 | OG000 |
| Group 2 | Placebo in Base Study | Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study | 0 | 1,888 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study
- 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. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.
- Time frame
- Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)
- Population
- Participants who received \>=1 qHPV vaccination or placebo injection in the Base Study 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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