LTFU+Control >=50YOA Group vs Historical Control >=50 YOA Group: Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall
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 | 0.00951 | 0.00752 | 0.012 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.047 | 0.0423 | 0.0521 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0375 | -0.043 | -0.0322 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.202 | 0.157 | 0.262 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.195 | 0.15 | 0.253 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on LTFU+Control >=50YOA Group than on Historical Control >=50 YOA Group | 26.7 | 23.3 | 31 | 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 | LTFU+Control >=50YOA Group | Participants 50 years of age or above (\>=50 YOA) (at the time of primary vaccination in the ZOSTER-006/022 studies) who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, i.e., combined group of LTFU group and Control group in the current ZOSTER-049 :EXT 006-022 study. | 69 | 7,258 | OG000 | ClinicalTrials.gov |
| Group 2 | Historical Control >=50 YOA Group | Hypothetical control group formed by using incidence rates estimated from actual placebo data in the ZOSTER-006/022 primary studies collected from participants \>=50 YOA (at time of primary vaccination in ZOSTER-006/022 studies). | 341 | 7,258 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall | ClinicalTrials.gov |
| Description | A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) and/or by HZ Ascertainment Committee (HZAC) determination, as per the algorithm pre-specified in the protocol.~As pre-specified in the protocol:~* due to the high VE observed in ZOSTER-006/022 studies, recipients of placebo in both studies were offered cross-vaccination with HZ/su. Since there was no placebo group in this study, historic controls were used for VE assessment. Incidence rates estimations on Historical Control group were done by utilizing Poisson regression model using placebo data from ZOSTER-006/022 studies to obtain the coefficients by age ranges.~* the participants in Control group were a subset of LTFU group that were randomized to serve as control for those who were vaccinated in this study, otherwise they were treated similarly as LTFU group, hence LTFU and Control groups were combined. | ClinicalTrials.gov |
| Time frame | During the total duration of ZOSTER-049:EXT 006-022 study (From Month 0 to Month 72) | ClinicalTrials.gov |
| Population | The analysis was performed on the Modified Total Vaccinated cohort (mTVC) - LTFU+Control group, which included all participants in the LTFU and Control groups combined, with efficacy data available for the specified analysis during the specified period, minus those participants who were not administered with the second vaccination during the ZOSTER-006/022 studies, or who developed a confirmed case of HZ prior to 1 month after the second vaccination in the ZOSTER-006/022 studies. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults | ClinicalTrials.gov |
| NCT number | NCT02723773 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Herpes Zoster, Herpes Zoster Vaccine | ClinicalTrials.gov |
| Interventions | Herpes Zoster Vaccine GSK1437173A | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2024-09-19 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02723773?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.