Zostavax™ vs Placebo: serious adverse events
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 | 0.0219 | 0.0193 | 0.0248 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.021 | 0.0185 | 0.0238 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000943 | -0.00288 | 0.00477 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.875 | 1.25 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.872 | 1.25 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Zostavax™ than on Placebo | 1,060 | 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 | Zostavax™ | Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™). | 243 | 11,094 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo. | 233 | 11,116 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Serious adverse events (SAEs) are presented that occurred from Day 1 to 182 postvaccination. Deaths that occurred any time during the study are also included. Non-serious AEs are presented for events that occurred from Day 1 to 42 postvaccination. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022) | ClinicalTrials.gov |
| NCT number | NCT00534248 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Shingles | ClinicalTrials.gov |
| Interventions | Zoster Vaccine, Live (Zostavax™), Comparator: Placebo | ClinicalTrials.gov |
| Lead sponsor | Merck Sharp & Dohme LLC | ClinicalTrials.gov |
| Results first posted | 2011-05-02 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00534248?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.