Comparison · NCT00090285-8e7424b9
LTFU (EXT2): Early Vaccination Group vs LTFU (EXT2): Catch-up Vaccination Group: LTFU (EXT2): Number of Participants Who Died
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. LTFU (EXT2): Early Vaccination Group vs LTFU (EXT2): Catch-up Vaccination Group: LTFU (EXT2): Number of Participants Who Died. Trial comparisons, record NCT00090285-8e7424b9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090285-8e7424b9
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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 | 0.00534 | 0.00228 | 0.0124 | wilson | |
| Risk in group 2 | 0.00231 | 0.000633 | 0.00837 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00304 | -0.00376 | 0.0103 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.32 | 0.45 | 11.9 | log | |
| Odds ratio, group 1 over group 2 | 2.32 | 0.449 | 12 | log | |
| Number needed to treat, for one more participant with the outcome on LTFU (EXT2): Early Vaccination Group than on LTFU (EXT2): Catch-up Vaccination Group | 329 | 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 | LTFU (EXT2): Early Vaccination Group | Participants received ≥1 dose of qHPV vaccine in Base Study and were followed up to a total of 10 years after their first dose of qHPV vaccine. No vaccinations were administered during Long-term Follow-up (LTFU) (EXT2). | 5 | 936 | OG000 |
| Group 2 | LTFU (EXT2): Catch-up Vaccination Group | Participants received placebo in Base Study and qHPV vaccine in EXT1 and were followed up to a total of 7 years after their first dose of qHPV vaccine. No vaccinations were administered during LTFU (EXT2). | 2 | 867 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- LTFU (EXT2): Number of Participants Who Died
- Description
- The number of participants who died was assessed.
- Time frame
- LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
- Population
- The population analyzed was all randomized participants receiving at least 1 dose of qHPV vaccine in the Base Study or EXT1 and enrolled in LTFU (EXT2).
Source ClinicalTrials.gov
Trial
- Title
- An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
- NCT number
- NCT00090285
- Phases
- PHASE3
- Conditions
- Condylomata Acuminata
- Interventions
- (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Comparator: placebo (unspecified)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2009-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090285?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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