Viewing Study NCT04505722



Ignite Creation Date: 2024-05-06 @ 3:03 PM
Last Modification Date: 2024-10-26 @ 1:42 PM
Study NCT ID: NCT04505722
Status: COMPLETED
Last Update Posted: 2024-06-14
First Post: 2020-07-31

Brief Title: A Study of Ad26COV2S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Sponsor: Janssen Vaccines Prevention BV
Organization: Janssen Vaccines Prevention BV

Study Overview

Official Title: A Randomized Double-blind Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26COV2S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: True
If Expanded Access, NCT#: NCT04817657
Has Expanded Access, NCT# Status: NO_LONGER_AVAILABLE
Acronym: ENSEMBLE
Brief Summary: The study will evaluate the efficacy of Ad26COV2S in the prevention of molecularly confirmed moderate to severecritical COVID-19 as compared to placebo in adult participants
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
VAC31518COV3001 OTHER Janssen Vaccines Prevention BV None