Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 10:25 PM
Study NCT ID:
NCT04894305
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Ad26.COV2.S in Healthy Adults (COVID-19)
Sponsor:
Janssen Vaccines & Prevention B.V.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Observer-blind Study to Compare the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S at a Single Dose of 5*10^10 vp in 2 Different Volumes in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2021-12
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:
None
Brief Summary:
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S (0.3 milliliter \[mL\] versus 0.5 mL) and to demonstrate non-inferiority (NI) of Ad26.COV2.S (0.3 mL versus 0.5 mL), 28 days after vaccination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
True
Is an FDA AA801 Violation?: