ENSEMBLE

E854996

ENSEMBLE is the large, global Phase 3 clinical trial that evaluated the safety and efficacy of Johnson & Johnson’s single-dose Ad26.COV2.S COVID-19 vaccine.

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Statements (40)

Predicate Object
instanceOf COVID-19 vaccine trial
Phase 3 clinical trial
clinical trial
controlType placebo
diseaseTarget COVID-19 NERFINISHED
doseRegimen single dose
efficacyAssessment monitored incidence of laboratory-confirmed COVID-19
endpoint assessment of safety profile
prevention of moderate to severe COVID-19
prevention of severe COVID-19
evaluatedProduct Ad26.COV2.S NERFINISHED
Johnson & Johnson single-dose COVID-19 vaccine
geographicScope multiple countries
interventionType vaccine
pathogenTarget SARS-CoV-2 NERFINISHED
population adult participants
primaryObjective evaluate efficacy of Ad26.COV2.S against COVID-19
regimenCharacteristic single-shot COVID-19 vaccine
relatedVaccineName Ad26.COV2.S COVID-19 vaccine GENERATED
Janssen COVID-19 Vaccine GENERATED
safetyAssessment monitored adverse events after vaccination
scope global
large
secondaryObjective evaluate immunogenicity of Ad26.COV2.S
evaluate safety of Ad26.COV2.S
sponsor Janssen Pharmaceutical Companies of Johnson & Johnson NERFINISHED
Johnson & Johnson NERFINISHED
sponsorCountry United States NERFINISHED
sponsorOrganizationType pharmaceutical company
sponsorType industry
studyDesign double-blind
placebo-controlled
randomized
therapeuticArea infectious diseases
vaccinology
trialCategory pivotal efficacy trial
trialContext COVID-19 pandemic NERFINISHED
trialPhase Phase 3
vaccinePlatform adenoviral vector vaccine
vaccineVector recombinant, replication-incompetent human adenovirus serotype 26 (Ad26)

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Ad26.COV2.S trialName ENSEMBLE