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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
900
Single dose of non-adjuvanted Quadrivalent VLP Vaccine
Single dose of non-adjuvanted Quadrivalent VLP Vaccine
Single dose of the licensed quadrivalent vaccine
Broward Research Group (BRG)
Hollywood, Florida, United States
Miami Research Associates (MRA)
South Miami, Florida, United States
Regional Clinical Research (RCR)
Endwell, New York, United States
Topstone Research
Toronto, Ontario, Canada
Diex Research Montreal
Montreal, Quebec, Canada
McGill University Health Center - Vaccine Study Center (MUHC)
Pierrefonds, Quebec, Canada
Diex Research Sherbroooke
Sherbrooke, Quebec, Canada
Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU)
Québec, Canada
Centre de Recherche St-Louis
Québec, Canada
Immunogenicity assessed by the geometric mean titers (GMT) of hemagglutination inhibition (HI) antibody against the homologous influenza strains
Immunogenicity will be assessed by the geometric mean titers (GMT) of hemagglutination inhibition (HI) antibody against the homologous influenza strains
Time frame: 21 days after injection
Immunogenicity assessed by GMT of HI antibody against heterologous strains
Immunogenicity will be assessed by GMT of HI antibody against heterologous strains
Time frame: 21 days after injection
Immunogenicity assessed by GMT of microneutralization (MN) antibody against homologous and heterologous strains
Immunogenicity will be assessed by GMT of microneutralization (MN) antibody against homologous and heterologous strains
Time frame: 21 days after injection
Immunogenicity assessed by GMT of single radial hemolysis (SRH) antibody against homologous and heterologous strains
Immunogenicity will be assessed by GMT of single radial hemolysis (SRH) antibody against homologous and heterologous strains
Time frame: 21 days after injection
Immunogenicity assessed by cell-mediated immune (CMI) response against homologous and heterologous strains
Immunogenicity will be assessed by cell-mediated immune (CMI) response against homologous and heterologous strains
Time frame: 21 days after injection
Incidence of Solicited Local and Systemic Reactions
Time frame: 21 days after injection
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 21 days after injection
Incidence of Abnormal Clinical Laboratory Tests
Time frame: 3 days after injection
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