Comparison · NCT03158220-sae
Women 16-26 Years of Age vs Women 27-45 Years of Age: 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. Women 16-26 Years of Age vs Women 27-45 Years of Age: serious adverse events. Trial comparisons, record NCT03158220-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03158220-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 | 0.0105 | 0.00483 | 0.0228 | wilson | |
| Risk in group 2 | 0.0125 | 0.00635 | 0.0245 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00197 | -0.0152 | 0.0117 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.842 | 0.294 | 2.41 | log | |
| Odds ratio, group 1 over group 2 | 0.84 | 0.29 | 2.44 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Women 16-26 Years of Age than on Women 27-45 Years of Age | 507 | from the risk difference interval | the interval includes no difference |
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 | Women 16-26 Years of Age | Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. | 6 | 570 | EG000 |
| Group 2 | Women 27-45 Years of Age | Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6. | 8 | 640 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 1 month post vaccination 3 (up to 7 months)
Source ClinicalTrials.gov
Trial
- Title
- Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
- NCT number
- NCT03158220
- Phases
- PHASE3
- Conditions
- Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
- Interventions
- V503
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03158220?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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