Ignite Creation Date:
2024-05-06 @ 10:36 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03300362
Status:
TERMINATED
Last Update Posted:
2018-11-23
First Post:
2017-09-26
Brief Title:
Improved Novel VaccIne CombinaTion InflUenza Study
Sponsor:
Barinthus Biotherapeutics
Organization:
Barinthus Biotherapeutics
Study Overview
Official Title:
A Phase IIb Study to Determine the Safety and Efficacy of Candidate INfluenza Vaccine MVA-NPM1 in Combination With Licensed InaCTivated inflUenza Vaccine in adultS Aged 65 Years and Above
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change to recommended season flu vaccine in UK
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INVICTUS
Brief Summary:
A Phase IIb randomised participant-blinded placebo-controlled multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine MVA- NPM1 and the annual recommended licensed inactivated influenza vaccine IIV Within the main cohort 100 participants will be recruited to an immunology sub-cohort
Detailed Description:
The efficacy of current seasonal influenza vaccines is limited in the face of antigenic mismatch between circulating viral strains and those in the given vaccine Additionally vaccination in older adults a major target group for vaccination prevents laboratory-confirmed influenza in only 30-40 compared to 70-90 in young adults The hypothesis in this Phase IIb efficacy study is that a new vaccine MVA-NPM1 with licensed inactivated influenza vaccine IIV in the older age group will be able to induce immune responses that protect individuals against influenza illness severity of symptoms and reduce viral shedding thereby increasing the protection conferred by seasonal influenza vaccine alone A total of 2030 participants who are 65 years of age or over and eligible for annual seasonal influenza vaccination and provide informed consent will be recruited to the study Potential volunteers will be mailed an invitation to take part by their GPs or recruited by local advertisements Participants will be randomised to receive either MVA- NPM1 with licensed IIV or saline placebo with licensed IIV In the first 28 days after vaccination participants will record adverse events using an electronic or paper diary The participants will be contacted by telephone 1 day and 7 days post-vaccination to enquire about any serious adverse events and support follow up During influenza season participants will record weekly whether or not they have had an influenza like illness ILI For every ILI episode experienced the participants will record the severity of their symptoms daily Among the participants a total of 100 volunteers 50 in each group will be recruited into an immunology sub-cohort They will have blood samples collected on the day of vaccination 1 week 3 weeks and 26 weeks post-vaccination for monitoring of laboratory adverse events and immunogenicity purposes
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