Comparison · NCT00534638-25b3ee36
Cervarix Pooled Group vs Engerix-B Pooled Group: Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects
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 Pooled Group vs Engerix-B Pooled Group: Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects. Trial comparisons, record NCT00534638-25b3ee36. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00534638-25b3ee36
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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 | 0.0731 | 0.0554 | 0.0958 | wilson | |
| Risk in group 2 | 0.0726 | 0.0584 | 0.0899 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000507 | -0.0243 | 0.0273 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.709 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.691 | 1.47 | log | |
| Number needed to treat, for one more participant with the outcome on Cervarix Pooled Group than on Engerix-B Pooled Group | 1,970 | 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 | Cervarix Pooled Group | Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 47 | 643 | OG000 |
| Group 2 | Engerix-B Pooled Group | Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 76 | 1,047 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects
- Description
MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
- Time frame
- From Dose 1 (at Day 0) until Month 12
- Population
This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
Source ClinicalTrials.gov
Trial
- Title
- Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents
- NCT number
- NCT00534638
- Phases
- PHASE4
- Conditions
- Infections, Papillomavirus
- Interventions
- Cervarix, Engerix-B
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2016-01-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00534638?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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