Comparison · NCT02663102-sae
Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: 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. Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: serious adverse events. Trial comparisons, record NCT02663102-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02663102-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 | 0.00437 | 0.00149 | 0.0128 | wilson | |
| Risk in group 2 | 0.00143 | 0.000252 | 0.00804 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00294 | -0.00427 | 0.0114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.06 | 0.319 | 29.4 | log | |
| Odds ratio, group 1 over group 2 | 3.07 | 0.319 | 29.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Fluarix Tetra Group 1 than on Fluarix Tetra Group 2 | 340 | 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 | Fluarix Tetra Group 1 | Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation). | 3 | 687 | EG000 |
| Group 2 | Fluarix Tetra Group 2 | Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation). | 1 | 701 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
- NCT number
- NCT02663102
- Phases
- Conditions
- Influenza, Human
- Interventions
- Data collection
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2024-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02663102?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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