NCT03301051

Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults

A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults 18-64 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,160 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 participants

Detailed description

This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2017-2018 influenza virus strains. Approximately 10,000 healthy male and female participants aged 18 to 64 years will be randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately 5,000 participants will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 μg/strain and approximately 5,000 participants will receive the placebo. Within the two treatment groups, participants will be stratified by site and two age groups (18-49 years of age and 50-64 years of age in a 1:1 ratio). Participants will participate in this study for approximately eight to ten months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent VLP Vaccine	Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
BIOLOGICAL	Placebo	Single dose of a Placebo

Timeline

• Start date: 2017-08-31
• Primary completion: 2018-05-02
• Completion: 2018-05-09
• First posted: 2017-10-04
• Last updated: 2023-08-14
• Results posted: 2023-08-14

Locations

73 sites across 7 countries: United States, Canada, Finland, Germany, Philippines, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study