Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults

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.

Timeline

Start

2017-09-29

Primary completion

2017-12-01

Completion

2017-12-01

Outcome

Met primary endpoint

paper Lot-to-lot consistency was met with the 95% confidence intervals of the D21 mean geometric titre ratios falling between 0.67 and 1.5 for all four strains. PMID 33581920 ↗

Publications

• Results Ward BJ, Seguin A, Couillard J, Trepanier S, Landry N. Phase III: Randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age. Vaccine. 2021 Mar 5;39(10):1528-1533. doi: 10.1016/j.vaccine.2021.01.004. Epub 2021 Feb 10.

Drugs

Indications