Zoster-022/006 Pooled GSK1437173A Group vs Zoster-022/006 Pooled Placebo Group: Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs
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 | 0.0146 | 0.0123 | 0.0173 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0164 | 0.014 | 0.0193 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0018 | -0.00549 | 0.00188 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.89 | 0.703 | 1.13 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.889 | 0.699 | 1.13 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Zoster-022/006 Pooled GSK1437173A Group than on Zoster-022/006 Pooled Placebo Group | 556 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Zoster-022/006 Pooled GSK1437173A Group | Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule. | 128 | 8,758 | OG000 | ClinicalTrials.gov |
| Group 2 | Zoster-022/006 Pooled Placebo Group | Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule. | 144 | 8,773 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs | ClinicalTrials.gov |
| Description | Fatal SAEs during the entire study period in subjects ≥ 70 YOA. | ClinicalTrials.gov |
| Time frame | During the entire study period (3 to 5 year period following Day 0) | ClinicalTrials.gov |
| Population | The analysis was based on the total vaccinated cohort, which included all vaccinated subjects with study vaccine or placebo administered. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older | ClinicalTrials.gov |
| NCT number | NCT01165229 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Herpes Zoster, Herpes Zoster Vaccine | ClinicalTrials.gov |
| Interventions | Herpes Zoster Vaccine GSK1437173A, Placebo | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2017-11-20 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01165229?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.