Comparison · NCT04074928-sae
QIVc vs Comparator QIV: 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. QIVc vs Comparator QIV: serious adverse events. Trial comparisons, record NCT04074928-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04074928-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 | 0.00939 | 0.0057 | 0.0154 | wilson | |
| Risk in group 2 | 0.0087 | 0.00422 | 0.0178 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000697 | -0.00916 | 0.00822 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.442 | 2.64 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.439 | 2.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on QIVc than on Comparator QIV | 1,430 | 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 | QIVc | Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | 15 | 1,597 | EG000 |
| Group 2 | Comparator QIV | Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains | 7 | 805 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
SAEs: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects Nonserious unsolicited AEs: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects Solicited AEs: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)
Source ClinicalTrials.gov
Trial
- Title
- Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
- NCT number
- NCT04074928
- Phases
- PHASE3
- Conditions
- Influenza, Human, Virus Diseases
- Interventions
- QIVc, Comparator QIV
- Lead sponsor
- Seqirus
- Results first posted
- 2022-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04074928?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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