Comparison · NCT04091451-sae
HZ/su Group vs Placebo Group: serious adverse events
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. HZ/su Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT04091451-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04091451-sae
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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 | 0.0784 | 0.0609 | 0.1 | wilson | |
| Risk in group 2 | 0.0604 | 0.0451 | 0.0804 | wilson | |
| Risk difference, group 1 minus group 2 | 0.018 | -0.00854 | 0.0448 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.885 | 1.91 | log | |
| Odds ratio, group 1 over group 2 | 1.32 | 0.877 | 2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HZ/su Group than on Placebo Group | 55.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | HZ/su Group | Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2. | 56 | 714 | EG000 |
| Group 2 | Placebo Group | Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2. | 43 | 712 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
Source ClinicalTrials.gov
Trial
- Title
Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster
- NCT number
- NCT04091451
- Phases
- PHASE3
- Conditions
- Herpes Zoster
- Interventions
- Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A), Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2025-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04091451?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.
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