Subjects will be screened up to 14 days (Day -14 to Day 0) before randomization.~On the planned day of vaccination (Day 1), subjects will be randomized in a 1:1:1:1 ratio (N = 30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection.~Approximately 5 subjects per group (N = 20) will be enrolled in parallel initially, and safety data through Day 8 will be collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects will be enrolled. If there are no safety concerns in the IDMC meeting, study enrollment will continue.~Blood and serum samples for safety laboratory tests and HAI titers will be obtained at baseline on Day 1 before administration of vaccine dose and after vaccination.
This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.