Fluarix Quadrivalent vs mRNA-1010: Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine
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 | 0.00825 | 0.00673 | 0.0101 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00733 | 0.0059 | 0.0091 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000926 | -0.00141 | 0.00328 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.836 | 1.52 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.835 | 1.52 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Fluarix Quadrivalent than on mRNA-1010 | 1,080 | 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 | Fluarix Quadrivalent | Participants received a single dose of Fluarix Quadrivalent by IM injection on Day 1. | 91 | 11,026 | OG000 | ClinicalTrials.gov |
| Group 2 | mRNA-1010 | Participants received a single dose of mRNA-1010 by IM injection on Day 1. | 81 | 11,055 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Seasonal Influenza A or B Virus Strains Regardless of Antigenic Match to Strains Selected for the Seasonal Vaccine | ClinicalTrials.gov |
| Description | Protocol-defined ILI: The presence of body temperature ≥37.5°C (≥99.5°F), accompanied by at least one of the respiratory illness symptoms (sore throat, cough, sputum production, wheezing, or difficulty breathing) and a positive RT-PCR for influenza. | ClinicalTrials.gov |
| Time frame | 14 days post-vaccination through Day 181 (Month 6) | ClinicalTrials.gov |
| Population | PP Set included all participants in the mITT Set (all randomized participants who received any study intervention except those who discontinued from the study prior to 14 days following administration of study intervention) who did not have major protocol deviations that could adversely impact efficacy, for example, disease or therapeutic intervention that might cause suboptimal response to the study intervention. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older | ClinicalTrials.gov |
| NCT number | NCT05566639 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Seasonal Influenza | ClinicalTrials.gov |
| Interventions | mRNA-1010, Fluarix Quadrivalent | ClinicalTrials.gov |
| Lead sponsor | ModernaTX, Inc. | ClinicalTrials.gov |
| Results first posted | 2025-01-16 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05566639?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.