Fluarix Tetra vs mRNA-1010: Number of Participants With Unsolicited AEs
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 | 0.246 | 0.231 | 0.261 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.264 | 0.248 | 0.28 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0179 | -0.0397 | 0.00404 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.932 | 0.855 | 1.02 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.91 | 0.811 | 1.02 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Fluarix Tetra than on mRNA-1010 | 56 | 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 Tetra | Participants received a single dose of Fluarix Tetra by IM injection on Day 1. | 749 | 3,048 | OG000 | ClinicalTrials.gov |
| Group 2 | mRNA-1010 | Participants received a single dose of mRNA-1010 by IM injection on Day 1. | 800 | 3,035 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With Unsolicited AEs | ClinicalTrials.gov |
| Description | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure. | ClinicalTrials.gov |
| Time frame | Up to 28 days post-vaccination | ClinicalTrials.gov |
| Population | The Safety Set included all participants who were randomized and received any study vaccination. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults | ClinicalTrials.gov |
| NCT number | NCT05415462 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Seasonal Influenza | ClinicalTrials.gov |
| Interventions | mRNA-1010, Fluarix Tetra | ClinicalTrials.gov |
| Lead sponsor | ModernaTX, Inc. | ClinicalTrials.gov |
| Results first posted | 2024-09-24 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05415462?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.