NCT03321968

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

A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,202 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Virus Diseases
• RNA Virus Infections
• Respiratory Tract Infections
• Respiratory Tract Disease
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent VLP Influenza Vaccine	Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine

Timeline

• Start date: 2017-09-29
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-10-26
• Last updated: 2023-08-04
• Results posted: 2023-08-04

Locations

10 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study