Comparison · NCT01610414-sae
GSK1437173A 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
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ConductScience Library. GSK1437173A Group vs Placebo Group: serious adverse events. Trial comparisons, record NCT01610414-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01610414-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 | 0.357 | 0.327 | 0.388 | wilson | |
| Risk in group 2 | 0.335 | 0.306 | 0.367 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0213 | -0.022 | 0.0646 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.938 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.907 | 1.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on GSK1437173A Group than on Placebo Group | 46.9 | 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 | GSK1437173A Group | Subjects received 2 doses of the candidate HZ vaccine GSK1437173A, administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. | 329 | 922 | EG000 |
| Group 2 | Placebo Group | Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of the non-dominant arm, according to a 0, 1-2-Months schedule. | 310 | 924 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period; SAEs: during the entire study period, up to 365 days post last vaccination (4 years approximately).
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
- NCT number
- NCT01610414
- Phases
- PHASE3
- Conditions
- Herpes Zoster
- Interventions
- Herpes Zoster vaccine GSK1437173A, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01610414?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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