Comparison · NCT01277042-sae
Cervarix Group vs Engerix 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
Cite this record
ConductScience Library. Cervarix Group vs Engerix Group: serious adverse events. Trial comparisons, record NCT01277042-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01277042-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 | 0.00495 | 0.00169 | 0.0145 | wilson | |
| Risk in group 2 | 0.00495 | 0.00169 | 0.0145 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.01 | 0.01 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.203 | 4.93 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.201 | 4.97 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 3 | 606 | EG000 |
| Group 2 | Engerix Group | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 3 | 606 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Serious adverse events were assessed from Month 0 up to Month 12. Systematically assessed frequent adverse events were assessed during 7 days (Days 0-6) post vaccination period.
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)
- NCT number
- NCT01277042
- Phases
- PHASE3
- Conditions
- Infections, Papillomavirus
- Interventions
- GSK580299 (CervarixTM), Engerix-BTM
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2013-12-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01277042?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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