At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10,160 enrolled
Drug / intervention
Quadrivalent VLP Vaccine +1 morebiological
Likely dose
Quadrivalent VLP Vaccine 30 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Quadrivalent VLP Vaccine and Placebo for Virus Diseases and 4 related conditions. Completed, enrolled 10,160 participants across 73 sites in 7 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVirus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza
CountriesCanada, Finland, Germany, Philippines, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedOct 2017
Primary CompletionMay 2018
Study CompletionMay 2018
TodayJul 2026
First PostedOct 4, 2017
Enrollment StartAug 31, 2017
Primary CompletionMay 2, 2018
Study CompletionMay 9, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.7 years ago
Interventions
Quadrivalent VLP Vaccinebiological
Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
Placebobiological
Single dose of a Placebo