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Clinical Trial Summary

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.


Clinical Trial Description

This randomized, observer-blind, multicenter, Phase 3 lot consistency study will be conducted at multiple sites in Canada. The composition of the Quadrivalent VLP Influenza Vaccine used in this study includes two influenza A virus strains and two influenza B virus strains based on the 2016-2017 recommended strains for vaccination in the Northern hemisphere. 1,200 healthy male and female participants aged 18 to 49 years will be randomized in a 1:1:1 ratio to one of three lots of the Quadrivalent VLP Influenza Vaccine (30 μg/strain). Participant will participate in this study for approximately 21 days, during which a first visit will be scheduled on Day 0 for screening, eligibility assessment, and vaccine administration; and on Day 21 for blood sample collection for immunogenicity assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03321968
Study type Interventional
Source Medicago
Contact
Status Completed
Phase Phase 3
Start date September 29, 2017
Completion date December 1, 2017

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