Quadrivalent VLP Vaccine vs Placebo: Number of Participants With ≥ Severe Related Unsolicited Reactions
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 | 0.00079 | 0.000307 | 0.00203 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00118 | 0.000542 | 0.00258 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000393 | -0.00187 | 0.001 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.668 | 0.189 | 2.36 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.188 | 2.37 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Quadrivalent VLP Vaccine than on Placebo | 2,540 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Quadrivalent VLP Vaccine | Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0. | 4 | 5,064 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received one IM injection of 0.5 mL of placebo on Day 0. | 6 | 5,072 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With ≥ Severe Related Unsolicited Reactions | ClinicalTrials.gov |
| Description | The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as definitely not related (clearly not related), probably not related (no medical evidence), possibly related (reasonable possibility of cause and effect), probably related (plausible biologic mechanism and temporal relationship) or definitely related (direct cause and effect relationship). The ≥ severe events included severe and potentially life-threatening and the related category included possibly related, probably related, and definitely related. AE and TEAEs are defined in outcome measure #10. | ClinicalTrials.gov |
| Time frame | Day 0 (post-vaccination) up to Day 21 | ClinicalTrials.gov |
| Population | SAS | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults | ClinicalTrials.gov |
| NCT number | NCT03301051 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza | ClinicalTrials.gov |
| Interventions | Quadrivalent VLP Vaccine, Placebo | ClinicalTrials.gov |
| Lead sponsor | Medicago | ClinicalTrials.gov |
| Results first posted | 2023-08-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03301051?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.