Comparison · NCT02663102-c089942b
Fluarix Tetra Group 1 vs Fluarix Tetra Group 2: Number of Participants With Unexpected Adverse Events (AEs)
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: Number of Participants With Unexpected Adverse Events (AEs). Trial comparisons, record NCT02663102-c089942b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02663102-c089942b
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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 | 0.169 | 0.143 | 0.199 | wilson | |
| Risk in group 2 | 0.0884 | 0.0696 | 0.112 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0804 | 0.0454 | 0.116 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.91 | 1.43 | 2.55 | log | |
| Odds ratio, group 1 over group 2 | 2.09 | 1.51 | 2.91 | log | |
| Number needed to treat, for one more participant with the outcome on Fluarix Tetra Group 1 than on Fluarix Tetra Group 2 | 12.4 | 8.64 | 22 | from the risk difference interval |
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). | 116 | 687 | OG000 |
| 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). | 62 | 701 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Unexpected Adverse Events (AEs)
- Description
- Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.
- Time frame
- During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
- Population
- The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.
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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