NCT03739112

Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly

A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,794 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 study was intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of VLP Influenza Vaccine (30 μg/strain) or of Comparator (15 μg/strain) was to be administered to 12,738 participants.

Detailed description

This randomized, observer-blind, active-controlled multicenter, Phase 3 study was conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine used in this study included a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2018-2019 influenza virus strains. A total of 12,794 healthy male and female participants aged 65 years and older were randomized in a 1:1 ratio into one of two parallel treatment groups, such that 6,396 participants were randomized to receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 μg/strain and 6,398 participants were randomized to receive the comparator. Within the two treatment groups, participants were stratified by site and two age groups (65-74 years of age and 75 years of age and older in a 2:1 ratio). Participants participated in this study for approximately nine months, during which a first visit was scheduled on Day 0 for screening and vaccine administration.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent VLP Vaccine	Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
BIOLOGICAL	Fluarix Quadrivalent® Comparator Vaccine	Single dose of a 15 μg/strain of Fluarix Quadrivalent® Comparator Vaccine

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-05-17
• Completion: 2019-07-16
• First posted: 2018-11-13
• Last updated: 2023-06-23
• Results posted: 2023-06-23

Locations

104 sites across 5 countries: United States, Canada, Finland, Germany, Thailand

Regulatory

• FDA-regulated drug study