Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04614948
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2020-11-03
Brief Title:
A Study of Ad26COV2S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults
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:
2024-09
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 2
Brief Summary:
The study will evaluate the efficacy of Ad26COV2S in the prevention of molecularly confirmed moderate to severecritical coronavirus disease-2019 COVID-19 as compared to placebo in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes safety and immunogenicity in the different study cohorts in open-label phase
Detailed Description:
The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19 Ad26COV2S a COVID-19 vaccine based on a human replication-incompetent Ad26 vector constructed to encode the severe acute respiratory syndrome coronavirus-2 SARS-CoV-2 virus spike S protein is being developed The study will consist of a screening phase up to 28 days study period 60-week and a long-term follow-up period 1 additional year The total study duration will be maximum 2 years and 3 months for the participants Assessments for efficacy COVID-19 signs and symptoms etc immunogenicity such as humoral immune responses and safety such as adverse events AEs monitoring will be performed throughout the study
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 |
|---|---|---|---|
| VAC31518COV3009 | OTHER | Janssen Vaccines Prevention BV | None |
| 2020-003643-29 | EUDRACT_NUMBER | None | None |