Ignite Creation Date:
2025-12-18 @ 9:08 AM
Ignite Modification Date:
2025-12-23 @ 10:24 PM
Study NCT ID:
NCT03721549
Status:
None
Last Update Posted:
2020-01-22 00:00:00
First Post:
2018-10-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Status:
None
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: