One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled study.
The purpose of this study is to evaluate, in a stepwise fashion, dose levels for an investigational quadrivalent influenza vaccine containing 2 influenza A strains and 2 influenza B strains. This is a multi-center, randomized, double-blind, placebo-controlled, dose escalating study in which up to 200 healthy adults age 65-75 years will be administered a single dose of either placebo or an investigational influenza vaccine (VAX2012Q, Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) at one of up to 3 dose levels. Fifty or up to 75 subjects will be enrolled in each dose level. Data for safety and immunogenicity will be collected for all dose levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Q-Pharm Pty Limited
Herston, Queensland, Australia
CMAX, a division of IDT Australia Limited
Adelaide, South Australia, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month and 1 year phone call.
Time frame: 21 days post-immunization; follow up at 6 months and one year
Immune response to vaccine will be measured by serum HAI levels
Time frame: 21 days post-immunization
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