Quadrivalent (30 μg) VLP Vaccine vs Active Comparator (Fluarix): Number of Participants With ≥ Severe Unsolicited TEAEs
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 | 0.0052 | 0.0037 | 0.00729 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00534 | 0.00382 | 0.00745 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000146 | -0.00273 | 0.00244 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.973 | 0.603 | 1.57 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.973 | 0.602 | 1.57 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Quadrivalent (30 μg) VLP Vaccine than on Active Comparator (Fluarix) | 6,870 | 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 | Quadrivalent (30 μg) VLP Vaccine | Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0. | 33 | 6,352 | OG000 | ClinicalTrials.gov |
| Group 2 | Active Comparator (Fluarix) | Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0. | 34 | 6,366 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With ≥ Severe Unsolicited TEAEs | ClinicalTrials.gov |
| Description | Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and pain). AE: any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry. ≥ severe events included severe and potentially life-threatening events. Any ≥ severe unsolicited reactions are reported. | ClinicalTrials.gov |
| Time frame | Day 0 (post-vaccination) to Day 21 | ClinicalTrials.gov |
| Population | SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly | ClinicalTrials.gov |
| NCT number | NCT03739112 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections | ClinicalTrials.gov |
| Interventions | Quadrivalent VLP Vaccine, Fluarix Quadrivalent® Comparator Vaccine | ClinicalTrials.gov |
| Lead sponsor | Medicago | ClinicalTrials.gov |
| Results first posted | 2023-06-23 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03739112?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.