Last updated on November 2018

Efficacy of a Plant-derived Quadrivalent VLP Vaccine in the Elderly

Brief description of study

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season in elderly adults 65 years of age and older. One dose of Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine (30 g/strain) or of Comparator (15 ug/strain) placebo will be administered to approximately 12,120 subjects.

Detailed Study 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 2018-2019 influenza virus strains.

Approximately 12,120 healthy male and female subjects aged 65 years and older will be randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately 6,060 subjects will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 g/strain and approximately 6,060 subjects will receive the comparator. Within the two treatment groups, subjects will be stratified by site and two age groups (65-74 years of age and 75 years of age and older in a 2:1 ratio).

Subjects 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.

Clinical Study Identifier: NCT03739112

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Recruitment Status: Open

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