Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04622592
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2020-10-16
Brief Title:
Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles QVLP Influenza Vaccine in Adults 65 Years of Age and Older
Sponsor:
Medicago
Organization:
Medicago
Study Overview
Official Title:
A Randomized Partially-Blinded Active Comparator-Controlled Dose-Ranging Safety Tolerability and Immunogenicity Phase 12 Study of an Adjuvanted Seasonal Recombinant Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This randomized partially-blinded active comparator-controlled was conducted at multiple sites globally The composition of QVLP used in this study includes a mix of recombinant H1 H3 and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains
In this study 3 dose levels 15 μgstrain 30 μgstrain and 45 μgstrain of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant full and half dose in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development
Participants participated in this study for up to approximately 13 months during which the first visit was scheduled for screening up to 7 days in advance of vaccine administration and the second visit on Day 0 was scheduled for vaccine administration Telephone contacts were made on Day 1 Day 8 and monthly starting after Day 28 until the end of the study for safety assessments including concomitant medication use review Blood draws at the clinic site for key safety assessments were made on Day 3 and Day 28 and for key immunogenicity assessments on Day 0 Day 28 Day 182 6-month follow-up and Day 365 12-month follow-up
In this study 3 dose levels 15 μgstrain 30 μgstrain and 45 μgstrain of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant full and half dose in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development
Participants participated in this study for up to approximately 13 months during which the first visit was scheduled for screening up to 7 days in advance of vaccine administration and the second visit on Day 0 was scheduled for vaccine administration Telephone contacts were made on Day 1 Day 8 and monthly starting after Day 28 until the end of the study for safety assessments including concomitant medication use review Blood draws at the clinic site for key safety assessments were made on Day 3 and Day 28 and for key immunogenicity assessments on Day 0 Day 28 Day 182 6-month follow-up and Day 365 12-month follow-up
Detailed Description:
In this study a partially-blinded design was applied whereby the following individuals did not have access to treatment allocation ie remained blind throughout the entire study duration the participants the Investigators and all personnel involved in the clinical conduct of the study except the staff involved in the preparation and administration of the study vaccine the quality assurance auditor and quality control reviewers Medicago clinical staff and medical staff involved in safety evaluations eg causality assessments and all personnel involved in sample analysis at the central and testing laboratories
A total of 209 participants were randomized to the study divided into 8 groups receiving different adjuvant dose level-combinations of QVLP or Fluzone HD Quad 60 µgstrain The majority of participants 126 participants received QVLP 30 μgstrain with full dose AS03 42 participants QVLP 30 μgstrain unadjuvanted 41 participants or Fluzone HD Quad 43 participants while in 5 other groups with 83 participants enrolled in total the enrollment was discontinued prematurely due to recruitment challenges caused by COVID-19 pandemic
A total of 209 participants were randomized to the study divided into 8 groups receiving different adjuvant dose level-combinations of QVLP or Fluzone HD Quad 60 µgstrain The majority of participants 126 participants received QVLP 30 μgstrain with full dose AS03 42 participants QVLP 30 μgstrain unadjuvanted 41 participants or Fluzone HD Quad 43 participants while in 5 other groups with 83 participants enrolled in total the enrollment was discontinued prematurely due to recruitment challenges caused by COVID-19 pandemic
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None