Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0383 | 0.0325 | 0.0451 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.029 | 0.0243 | 0.0347 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00926 | 0.00119 | 0.0175 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.32 | 1.04 | 1.68 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.33 | 1.04 | 1.71 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Cervarix/Engerix-B A Group than on Cervarix/Engerix-B B Group | 108 | 57.1 | 843 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Cervarix/Engerix-B A Group | The A group includes subjects from communities where 70% of male and female adolescents 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 to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A 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. | 139 | 3,629 | OG000 | ClinicalTrials.gov |
| Group 2 | Cervarix/Engerix-B B Group | The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 117 | 4,029 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | ClinicalTrials.gov |
| Description | The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group).~Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure. | ClinicalTrials.gov |
| Time frame | At the time of Visit 5 (i.e. at 18.5 years of age) | ClinicalTrials.gov |
| 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. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents | ClinicalTrials.gov |
| NCT number | NCT00534638 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Infections, Papillomavirus | ClinicalTrials.gov |
| Interventions | Cervarix, Engerix-B | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2016-01-26 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00534638?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.