NCT02768805

Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Virus Diseases
• RNA Virus Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	15 µg/strain of Quadrivalent VLP Vaccine	Single dose of non-adjuvanted Quadrivalent VLP Vaccine
BIOLOGICAL	30 µg/strain of Quadrivalent VLP Vaccine	Single dose of non-adjuvanted Quadrivalent VLP Vaccine
BIOLOGICAL	15 µg/strain of the licensed quadrivalent vaccine	Single dose of the licensed quadrivalent vaccine

Timeline

• Start date: 2016-03-02
• Primary completion: 2016-05-17
• Completion: 2016-11-26
• First posted: 2016-05-11
• Last updated: 2020-06-11

Locations

9 sites across 2 countries: United States, Canada