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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Low dose of KBP-V001
Intermediate dose of KBP-V001
High dose of KBP-V001
Meridian Clinical Research
Omaha, Nebraska, United States
Solicited administration site reactions
Occurrences of Adverse Events
Time frame: 7 days after vaccination
Solicited systemic events
Occurrences of Adverse Events
Time frame: 7 days after vaccination
Number of Unsolicited Adverse Events
Safety Endpoint
Time frame: 43 days after vaccination
Number of Serious Adverse Events and Medically Attended Events
Safety Endpoint
Time frame: 181 days after vaccination
Vaccine HAI antibody Titers
Vaccine HAI antibody Titers for each treatment group
Time frame: Day 1, 29, 43, 181
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