Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03880474
Status:
TERMINATED
Last Update Posted:
2021-04-26
First Post:
2019-02-21
Brief Title:
Efficacy of Candidate Influenza Vaccine MVA-NPM1 in Adults
Sponsor:
Barinthus Biotherapeutics
Organization:
Barinthus Biotherapeutics
Study Overview
Official Title:
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NPM1 in Adults Aged 18 Years and Over
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial is being stopped for futility Season 2 cancelled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2b Study to Determine the Efficacy of Candidate Influenza Vaccine MVA-NPM1 in Adults aged 18 years and over To assess the effect of MVA-NPM1 on the reduction of laboratory confirmed influenza when given as an adjunct to licensed quadrivalent influenza vaccine QIV in adults
Detailed Description:
This is a Phase 2b multicentre randomised single-blind study in up to 6000 adults to compare the efficacy safety and immunogenicity of MVA-NPM1 when given as an adjunct to a standard licensed adult dose of QIV The study will be conducted on an outpatient basis and will run over two consecutive influenza seasons It is aimed to recruit 2200 participants in Season 1 and 2800-3800 participants in Season 2
Study Oversight
Has Oversight DMC:
None
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?:
None