NCT02831751

Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults

A Randomized, Observer-Blind, Multicenter, Phase 2 Study to Assess the Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults of 65 Years of Age or Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.

Detailed description

This randomized, observer-blind, multicenter, Phase 2 study will be conducted at multiple sites across the United States and Canada. The influenza strain composition of the Quadrivalent VLP Vaccine used in this study includes 2 influenza A virus strains (A/California/7/2009 \[H1N1\] and A/Switzerland/9715293/2013 \[H3N2\]) and 2 influenza B virus strains (B/Phuket/3073/2013 \[Yamagata lineage\] and B/Brisbane/60/2008 \[Victoria lineage\]), based on the 2015-2016 recommended World Health Organization (WHO) strains for vaccination in the Northern hemisphere. Approximately 1000 elderly male and female subjects, aged 65 years or older, will be randomized in a 1:1:1:1 ratio to 1of 4 parallel treatment groups such that 500 subjects receive Quadrivalent VLP Vaccine (250 each for the 30 µg/strain and 60 µg/strain groups), 250 subjects receive FluLaval® Tetra (15 µg/strain) and 250 subjects receive Fluzone® HD (60 µg/strain). Subjects in each group will be stratified into 2 age strata: 65 to 74 years and 75 years old and older, where 70 % of subjects will be enrolled into the 65 to 74 years old age group and 30 % into the 75 years old or older group. Subjects will participate in this study for approximately 8 months, during which 5 visits will be scheduled, and phone contact will be made on Day 1, Day 8, and every 2 months thereafter for up to 6 months post-Day 21 visit (Day 201). Blood samples will be collected for immunogenicity analyses at Days 0 and 21 for all subjects. Safety laboratory assessments will be performed at Screening, on Day 3 and within 48 hours of Day 3 results availability, for grade 3 or grade 4 abnormalities or if deemed necessary by the investigator or early termination. Subsequent follow-up of clinically significant laboratory abnormalities will be done according to the investigator's discretion.. Subjects will be monitored throughout the study for safety, including the reporting of solicited local and systemic reactions.

Conditions

• Virus Diseases
• RNA Virus Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	30 µg/strain of Quadrivalent VLP Vaccine	Single dose of non-adjuvanted Quadrivalent VLP Vaccine
BIOLOGICAL	60 µg/strain of Quadrivalent VLP Vaccine	Single dose of non-adjuvanted Quadrivalent VLP Vaccine
BIOLOGICAL	FluLaval® Tetra (15 µg/strain)	Single dose of a licensed quadrivalent vaccine
BIOLOGICAL	Fluzone® High-Dose (60 µg/strain)	Single dose of a licensed trivalent vaccine

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-07-01
• Completion: 2017-01-01
• First posted: 2016-07-13
• Last updated: 2019-10-25

Locations

15 sites across 2 countries: United States, Canada