Fluarix Tetra vs mRNA-1010: Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus
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 | 0.0181 | 0.0139 | 0.0236 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0215 | 0.0169 | 0.0273 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00335 | -0.0106 | 0.00379 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.844 | 0.59 | 1.21 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.841 | 0.583 | 1.21 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Fluarix Tetra than on mRNA-1010 | 299 | 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. | 54 | 2,979 | OG000 | ClinicalTrials.gov |
| Group 2 | mRNA-1010 | Participants received a single dose of mRNA-1010 by IM injection on Day 1. | 64 | 2,980 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Strain of Influenza Virus | ClinicalTrials.gov |
| Description | A protocol-defined ILI was determined by the occurrence of at least 1 respiratory illness symptom concurrently with at least 1 systemic symptom, or the occurrence of any 2 or more respiratory symptoms. Respiratory symptoms included sore throat, cough/rhinorrhea/nasal congestion (≥1 of the 3 symptoms count as 1 respiratory symptom), sputum production, wheezing, or difficulty breathing. Systemic symptoms included body temperature \>37.2 degrees Celsius (°C) (\>99 degrees Fahrenheit \[°F\]), chills, tiredness, headache, myalgia, nausea/vomiting, or diarrhea. | ClinicalTrials.gov |
| Time frame | 14 days post-vaccination through Day 181 (Month 6) | ClinicalTrials.gov |
| Population | The Modified Intent-to-Treat (mITT) Set included all participants who were randomized and received any study vaccination and who provided any follow-up for ILI beginning at least 14 days following administration of study intervention. | 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.