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 COVID-19 Vaccine
surface form: 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 Pharmaceuticals
surface form: Janssen Vaccines & Prevention B.V.
sponsorParentCompany Johnson & Johnson
startYear 2020
targetDisease COVID-19 pandemic
surface form: COVID-19
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.