Comparison · NCT00316706-sae
Cervarix Group vs Havrix Group: serious adverse events
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. Cervarix Group vs Havrix Group: serious adverse events. Trial comparisons, record NCT00316706-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00316706-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 | 0.0527 | 0.0378 | 0.0731 | wilson | |
| Risk in group 2 | 0.00808 | 0.00346 | 0.0188 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0446 | 0.0263 | 0.0655 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.53 | 2.56 | 16.6 | log | |
| Odds ratio, group 1 over group 2 | 6.83 | 2.65 | 17.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cervarix Group than on Havrix Group | 22.4 | 15.3 | 38.1 | from the risk difference interval |
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 | Cervarix Group | Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48. | 33 | 626 | EG000 |
| Group 2 | Havrix Group | Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24. | 5 | 619 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group
Source ClinicalTrials.gov
Trial
- Title
- Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
- NCT number
- NCT00316706
- Phases
- PHASE3
- Conditions
- Cervical Intraepithelial Neoplasia, Papillomavirus Infection
- Interventions
- GSK Biologicals' HPV-16/18 Vaccine (Cervarix™), Havrix™
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2010-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00316706?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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