ENSEMBLE trial

E241392

The ENSEMBLE trial was a large, global Phase 3 clinical study designed to evaluate the safety and efficacy of Janssen’s single-dose COVID-19 vaccine in preventing SARS-CoV-2 infection and severe disease.

All labels observed (1)

Label Occurrences
ENSEMBLE trial canonical 1

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf COVID-19 vaccine trial ⓘ
Phase 3 clinical trial ⓘ
clinical trial ⓘ
allocation 1:1 vaccine to placebo ⓘ
design double-blind ⓘ
placebo-controlled ⓘ
randomized ⓘ
developerOfInvestigationalProduct Ad26.COV2.S ⓘ
doseRegimen single dose ⓘ
endpoint COVID-19–related death ⓘ
COVID-19–related hospitalization ⓘ
moderate to severe COVID-19 ⓘ
severe COVID-19 ⓘ
virologically confirmed COVID-19 ⓘ
evaluatedVaccine Janssen single-dose COVID-19 vaccine ⓘ
geographicScope multinational ⓘ
includedRegion Africa ⓘ
Asia ⓘ
Europe ⓘ
North America ⓘ
South America ⓘ
interventionModel parallel assignment ⓘ
masking care provider ⓘ
investigator ⓘ
outcomes assessor ⓘ
participant ⓘ
phase Phase 3 ⓘ
population adults 18 years of age and older ⓘ
primaryObjective evaluate efficacy of a single dose of Ad26.COV2.S in preventing moderate to severe COVID-19 ⓘ
regulatoryUse supported emergency use authorization applications ⓘ
relatedTo Janssen COVID-19 Vaccine ⓘ
routeOfAdministration intramuscular injection ⓘ
safetyAssessment adverse events of special interest ⓘ
local adverse events ⓘ
medically attended adverse events ⓘ
serious adverse events ⓘ
systemic adverse events ⓘ
safetyPopulation all participants who received at least one dose of study vaccine or placebo ⓘ
scope global ⓘ
secondaryObjective evaluate efficacy in preventing severe COVID-19 ⓘ
evaluate safety of Ad26.COV2.S ⓘ
sponsor Janssen Pharmaceuticals ⓘ
Janssen Vaccines & Prevention B.V. ⓘ
sponsorParentCompany Johnson & Johnson ⓘ
startYear 2020 ⓘ
targetDisease COVID-19 ⓘ
linked to: COVID-19 pandemic
targetPathogen SARS-CoV-2 ⓘ
trialType interventional ⓘ

How these facts were elicited

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.