Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

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 demonstrate that the immunogenicity profile of the Quadrivalent
      VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure
      criteria. The study will also help to define the optimal dose, 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 900 healthy subjects will be randomized in a 1:1:1 ratio to 1 of 3 parallel
      treatment groups. Subjects in each group will be stratified into 2 age strata: 18 to 49 years
      and 50 to 64 years in a 2:1 ratio.

      Subjects will receive one intramuscular (IM) injection of their assigned vaccine:

        -  15 µg/strain of Quadrivalent VLP Vaccine, or

        -  30 µg/strain of Quadrivalent VLP Vaccine, or

        -  15 µg/strain of the licensed and commercially available quadrivalent vaccine FluLaval®
           Tetra.

      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). 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.
    

Intervention name(s): 15 µg/strain of Quadrivalent VLP Vaccine; 30 µg/strain of Quadrivalent VLP Vaccine; 15 µg/strain of the licensed quadrivalent vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose of non-adjuvanted Quadrivalent VLP Vaccine; Single dose of non-adjuvanted Quadrivalent VLP Vaccine; Single dose of the licensed quadrivalent vaccine
Other intervention name(s): FluLaval® Tetra; FluLaval® Quadrivalent
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Human; RNA Virus Infections; Immunologic; Immunogenic Factors; Physiological Effects of Drug; Virus Diseases; Orthomyxoviridae Infections; Infection