Comparison · NCT00534638-771d4f2b
Cervarix/Engerix-B Pooled Group vs Engerix-B Group: Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types
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/Engerix-B Pooled Group vs Engerix-B Group: Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types. Trial comparisons, record NCT00534638-771d4f2b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00534638-771d4f2b
On this page
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 | 0.00282 | 0.00148 | 0.00535 | wilson | |
| Risk in group 2 | 0.0161 | 0.0111 | 0.0233 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0133 | -0.0206 | -0.00765 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.175 | 0.0827 | 0.372 | log | |
| Odds ratio, group 1 over group 2 | 0.173 | 0.0812 | 0.369 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cervarix/Engerix-B Pooled Group than on Engerix-B Group | 75.4 | 48.5 | 131 | 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/Engerix-B Pooled Group | Pooled A and B group: This pooled group includes subjects from communities where 70% of male and female adolescents (A group) or 70% of female adolescents (B group) were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants (A group) or female participants (B group) to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects (A group) or vaccinated females (B group) were randomized to Cervarix). Finally, subjects from this pooled group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 9 | 3,192 | OG000 |
| Group 2 | Engerix-B Group | In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 27 | 1,679 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types
- Description
The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
- Time frame
- At the time of Visit 5 (i.e. at 18.5 years of age)
- Population
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00534638-771d4f2b