Comparison · NCT02485301-996a5f8c
GSK3390107A Group vs Placebo+GSK3390107A Group: Number of Subjects With Unsolicited Adverse Events (AEs)
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. GSK3390107A Group vs Placebo+GSK3390107A Group: Number of Subjects With Unsolicited Adverse Events (AEs). Trial comparisons, record NCT02485301-996a5f8c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02485301-996a5f8c
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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 | 0.164 | 0.139 | 0.192 | wilson | |
| Risk in group 2 | 0.158 | 0.134 | 0.186 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00576 | -0.0315 | 0.0431 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.823 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.792 | 1.37 | log | |
| Number needed to treat, for one more participant with the outcome on GSK3390107A Group than on Placebo+GSK3390107A Group | 174 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of the investigational GSK3390107A vaccine, at Day 0, administered intramuscularly, into the deltoid region of the arm. | 123 | 749 | OG000 |
| Group 2 | Placebo+GSK3390107A Group | Healthy male or female subjects, aged 18 or older at the time of screening, who received one dose of placebo at Day 0 and one dose of the investigational GSK3390107A vaccine at Month 6, administered intramuscularly, into the deltoid region of the arm. | 119 | 751 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Subjects With Unsolicited Adverse Events (AEs)
- Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
- Time frame
- During the 30-Day (Days 0-29) post-vaccination period
- Population
- The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
- NCT number
- NCT02485301
- Phases
- PHASE2
- Conditions
- Virus Diseases
- Interventions
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2018-01-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02485301?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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