D-QIV vs Control: Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.
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 | 0.0035 | 0.00227 | 0.00541 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0154 | 0.0126 | 0.019 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0119 | -0.0157 | -0.00848 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.227 | 0.14 | 0.368 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.224 | 0.138 | 0.365 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on D-QIV than on Control | 83.7 | 63.7 | 118 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | D-QIV | Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). | 20 | 5,707 | OG000 | ClinicalTrials.gov |
| Group 2 | Control | In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). | 88 | 5,697 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | ClinicalTrials.gov |
| Description | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. | ClinicalTrials.gov |
| Time frame | During the surveillance period (approximately 6 to 8 months) | ClinicalTrials.gov |
| Population | The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children | ClinicalTrials.gov |
| NCT number | NCT01439360 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Influenza | ClinicalTrials.gov |
| Interventions | Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A, Havrix Junior, Prevenar 13, Varivax/ProVarivax, Varilrix | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Results first posted | 2017-03-08 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01439360?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.