RZV Group vs Placebo Group: Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)
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 | 0 | 0.00125 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000326 | 0.0000576 | 0.00185 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000326 | -0.00185 | 0.000954 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one fewer participant with the outcome on RZV Group than on Placebo Group | 3,064 | 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 | RZV Group | Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. | 0 | 3,064 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo Group | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. | 1 | 3,064 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years) | ClinicalTrials.gov |
| Description | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination. | ClinicalTrials.gov |
| Time frame | From first vaccination (Day 1) up to study end (duration of approximately 2 years) | ClinicalTrials.gov |
| Population | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years | ClinicalTrials.gov |
| NCT number | NCT04869982 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Herpes Zoster | ClinicalTrials.gov |
| Interventions | RZV, Placebo | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2024-09-19 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04869982?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.