Comparison · NCT01229267-sae
V212 [Including High Antigen Lot] vs Placebo: 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. V212 [Including High Antigen Lot] vs Placebo: serious adverse events. Trial comparisons, record NCT01229267-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01229267-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 | 0.639 | 0.602 | 0.675 | wilson | |
| Risk in group 2 | 0.675 | 0.635 | 0.713 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0358 | -0.0889 | 0.0179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.947 | 0.873 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.853 | 0.672 | 1.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on V212 [Including High Antigen Lot] than on Placebo | 27.9 | 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 | V212 [Including High Antigen Lot] | Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT. | 420 | 657 | EG000 |
| Group 2 | Placebo | Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT. | 374 | 554 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected up to approximately 5 years after vaccination 1.
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
- NCT number
- NCT01229267
- Phases
- PHASE3
- Conditions
- Herpes Zoster
- Interventions
- V212, Matching placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2018-07-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01229267?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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