Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT02768805
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
Sponsor:
Medicago
Organization:
Study Overview
Official Title:
Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
Status:
COMPLETED
Status Verified Date:
2020-06
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 Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.
Detailed Description:
This randomized, observer-blind, multicenter, Phase 2 study will be conducted at multiple sites across the United States and Canada.
The influenza strain composition of the Quadrivalent VLP Vaccine used in this study includes 2 influenza A virus strains (A/California/7/2009 \[H1N1\] and A/Switzerland/9715293/2013 \[H3N2\]) and 2 influenza B virus strains (B/Phuket/3073/2013 \[Yamagata lineage\] and B/Brisbane/60/2008 \[Victoria lineage\]), based on the 2015-2016 recommended World Health Organization (WHO) strains for vaccination in the Northern hemisphere.
Approximately 900 healthy subjects will be randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. Subjects in each group will be stratified into 2 age strata: 18 to 49 years and 50 to 64 years in a 2:1 ratio.
Subjects will receive one intramuscular (IM) injection of their assigned vaccine:
* 15 µg/strain of Quadrivalent VLP Vaccine, or
* 30 µg/strain of Quadrivalent VLP Vaccine, or
* 15 µg/strain of the licensed and commercially available quadrivalent vaccine FluLaval® Tetra.
Subjects will participate in this study for approximately 8 months, during which 5 visits will be scheduled, and phone contact will be made on Day 1, Day 8, and every 2 months thereafter for up to 6 months post-Day 21 visit (Day 201). Safety laboratory assessments will be performed at Screening, on Day 3 and within 48 hours of Day 3 results availability, for grade 3 or grade 4 abnormalities or if deemed necessary by the investigator or early termination.
The influenza strain composition of the Quadrivalent VLP Vaccine used in this study includes 2 influenza A virus strains (A/California/7/2009 \[H1N1\] and A/Switzerland/9715293/2013 \[H3N2\]) and 2 influenza B virus strains (B/Phuket/3073/2013 \[Yamagata lineage\] and B/Brisbane/60/2008 \[Victoria lineage\]), based on the 2015-2016 recommended World Health Organization (WHO) strains for vaccination in the Northern hemisphere.
Approximately 900 healthy subjects will be randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. Subjects in each group will be stratified into 2 age strata: 18 to 49 years and 50 to 64 years in a 2:1 ratio.
Subjects will receive one intramuscular (IM) injection of their assigned vaccine:
* 15 µg/strain of Quadrivalent VLP Vaccine, or
* 30 µg/strain of Quadrivalent VLP Vaccine, or
* 15 µg/strain of the licensed and commercially available quadrivalent vaccine FluLaval® Tetra.
Subjects will participate in this study for approximately 8 months, during which 5 visits will be scheduled, and phone contact will be made on Day 1, Day 8, and every 2 months thereafter for up to 6 months post-Day 21 visit (Day 201). Safety laboratory assessments will be performed at Screening, on Day 3 and within 48 hours of Day 3 results availability, for grade 3 or grade 4 abnormalities or if deemed necessary by the investigator or early termination.
Study Oversight
Has Oversight DMC:
False
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?: