Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults
- Conditions
- Influenza
- Registration Number
- NCT04439695
- Lead Sponsor
- KBio Inc
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Solicited administration site reactions 7 days after vaccination Occurrences of Adverse Events
Solicited systemic events 7 days after vaccination Occurrences of Adverse Events
- Secondary Outcome Measures
Name Time Method Number of Serious Adverse Events and Medically Attended Events 181 days after vaccination Safety Endpoint
Number of Unsolicited Adverse Events 43 days after vaccination Safety Endpoint
Vaccine HAI antibody Titers Day 1, 29, 43, 181 Vaccine HAI antibody Titers for each treatment group
Trial Locations
- Locations (1)
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research🇺🇸Omaha, Nebraska, United States