Respiratory Tract Infections Clinical Trial
Official title:
Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age
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.
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