aQIV (≥6 to <72 Months) vs TIV/QIV (≥6 to <72 Months): deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.000187 | 0.0000331 | 0.00106 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000569 | 0.000194 | 0.00167 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000382 | -0.0015 | 0.000569 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.329 | 0.0342 | 3.16 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.329 | 0.0342 | 3.16 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on aQIV (≥6 to <72 Months) than on TIV/QIV (≥6 to <72 Months) | 2,620 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | aQIV (≥6 to <72 Months) | Subjects ≥6 to \<72 months of age who received aQIV | 1 | 5,339 | EG000 | ClinicalTrials.gov |
| Group 2 | TIV/QIV (≥6 to <72 Months) | Subjects ≥6 to \<72 months of age who received TIV/QIV | 3 | 5,272 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | Day 1 to Day 366 (for vaccine non-naive subjects) and Day 1 to Day 390 (for vaccine naive subjects). AEs are reported for the aQIV arm and the TIV/QIV arm. Although randomization was stratified by vaccination influenza history (naive vs non-naive), which determined the number of doses of vaccine a subject received, the intention was to report the safety results for each arm as a whole. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children. | ClinicalTrials.gov |
| NCT number | NCT01964989 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza Virus | ClinicalTrials.gov |
| Interventions | Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV) | ClinicalTrials.gov |
| Lead sponsor | Seqirus | ClinicalTrials.gov |
| Results first posted | 2023-03-27 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01964989?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.