Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 4:42 PM
Study NCT ID:
NCT04540393
Status:
WITHDRAWN
Last Update Posted:
2021-10-01
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD1222 Vaccine for the Prevention of COVID-19
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase III Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was put on hold in September 2020 due to a safety concern in another trial but never restarted. In the meantime our clinical development program now includes a similar study with a different design, which we prefer to complete now.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation
Detailed Description:
This is a prospective, multicentre, open-label, non-comparative clinical study, designed to provide data on the use of AZD1222 in the Russian Federation. The protocol is part of the international AstraZeneca program of AZD1222 development with several studies being conducted in the UK, US, Japan, and other countries. This study is intended for registration purposes of AZD1222 in Russia. The study data will complement the data from other pivotal controlled studies conducted in other countries with the Russian participants' data, which is considered the most expedited way to make the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccine available to the Russian Federation for contribution to controlling the current public health crisis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: