Comparison · NCT02545543-1a74b695
Seqirus Quadrivalent Influenza Vaccine vs Comparator Quadrivalent Influenza Vaccine: Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
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. Seqirus Quadrivalent Influenza Vaccine vs Comparator Quadrivalent Influenza Vaccine: Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). Trial comparisons, record NCT02545543-1a74b695. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02545543-1a74b695
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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 | 0.00473 | 0.0024 | 0.0093 | wilson | |
| Risk in group 2 | 0.00357 | 0.00098 | 0.0129 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00116 | -0.00848 | 0.00641 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.282 | 6.22 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.281 | 6.26 | log | |
| Number needed to treat, for one more participant with the outcome on Seqirus Quadrivalent Influenza Vaccine than on Comparator Quadrivalent Influenza Vaccine | 865 | 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 | Seqirus Quadrivalent Influenza Vaccine | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | 8 | 1,692 | OG000 |
| Group 2 | Comparator Quadrivalent Influenza Vaccine | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination. | 2 | 560 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).
- Description
- Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.
- Time frame
- 180 days after the last vaccination dose.
- Population
- The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
- NCT number
- NCT02545543
- Phases
- PHASE3
- Conditions
- Influenza, Human
- Interventions
- Seqirus QIV, Comparator QIV
- Lead sponsor
- Seqirus
- Results first posted
- 2017-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02545543?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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