Comparison · NCT00834106-sae
qHPV vs Placebo: serious adverse events
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 vs Placebo: serious adverse events. Trial comparisons, record NCT00834106-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00834106-sae
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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 | 0.0254 | 0.0185 | 0.0346 | wilson | |
| Risk in group 2 | 0.0287 | 0.0214 | 0.0384 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00335 | -0.0152 | 0.00845 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.883 | 0.574 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 0.88 | 0.565 | 1.37 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on qHPV than on Placebo | 298 | 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 | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 | 38 | 1,499 | EG000 |
| Group 2 | Placebo | Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 | 43 | 1,498 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 90 months
Source ClinicalTrials.gov
Trial
- Title
- Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
- NCT number
- NCT00834106
- Phases
- PHASE3
- Conditions
- HPV Infections
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: placebo (unspecified)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2017-10-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00834106?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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