Comparison · NCT02242643-sae
FluLaval™ Quadrivalent Group vs Fluzone® Quadrivalent 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
Cite this record
ConductScience Library. FluLaval™ Quadrivalent Group vs Fluzone® Quadrivalent Group: serious adverse events. Trial comparisons, record NCT02242643-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02242643-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 | 0.00414 | 0.00177 | 0.00966 | wilson | |
| Risk in group 2 | 0.00329 | 0.00128 | 0.00842 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000856 | -0.0048 | 0.00673 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.339 | 4.68 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.338 | 4.71 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FluLaval™ Quadrivalent Group than on Fluzone® Quadrivalent Group | 1,170 | 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 | FluLaval™ Quadrivalent Group | Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). | 5 | 1,207 | EG000 |
| Group 2 | Fluzone® Quadrivalent Group | Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). | 4 | 1,217 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
- NCT number
- NCT02242643
- Phases
- PHASE3
- Conditions
- Influenza
- Interventions
- FluLaval™ Quadrivalent, Fluzone® Quadrivalent
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2016-04-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02242643?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.
For software
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