Quadrivalent VLP Vaccine vs Placebo: Number of Participants With at Least One Immediate Complaint
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 | 0.0871 | 0.0796 | 0.0952 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0743 | 0.0674 | 0.0819 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0128 | 0.00215 | 0.0234 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.17 | 1.03 | 1.34 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.19 | 1.03 | 1.37 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Quadrivalent VLP Vaccine than on Placebo | 78.4 | 42.8 | 466 | from the risk difference interval | 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. | 441 | 5,064 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received one IM injection of 0.5 mL of placebo on Day 0. | 377 | 5,072 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With at Least One Immediate Complaint | ClinicalTrials.gov |
| Description | Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. | ClinicalTrials.gov |
| Time frame | 15 minutes post vaccination | 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.