Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Medicago
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.
Age
18–64
Sex
ALL
Healthy volunteers
Accepted
