This study aims to evaluate the safety and immunogenicity of an inactivated cell culture derived H7N9 vaccine in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Comparison of each dose of vaccine
Comparison of each dose of vaccine
Comparison of each dose of vaccine
National Taiwan University Hospital
Taipei, Taiwan
Safety of AT-501 vaccine measured by Adverse Event
Phase 1 * Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period after the first and second dose of administered vaccine. * Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period after each administered vaccine. * Occurrence of overall adverse events and serious adverse events during the entire period of study.
Time frame: 1 year from the start of study enrolment
Immunogenicity of AT-501 vaccine measured by HI titers
Phase 2 HI titers as follows: * Seroconversion Rate (SCR) at day 22 and 43 * Seroconversion Factor (SCF) at day 22 and day 43 * Seroprotection Rate (SPR) at day 22 and day 43
Time frame: 1 year from the start of study enrolment
Immunogenicity of AT-501 vaccine measured HI and neutralizing antibody titers
Phase 1 * Change of antibody titers from baseline to day 22 and day 43 * Geometric Mean Titer (GMT) of both serum HI titers and neutralizing antibody titers, pre-vaccination and day 22 and day 43 post-vaccination
Time frame: 1 year from the start of study enrolment
Safety of AT-501 vaccine measured by Adverse Event
Phase 2 * Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period after the first and second dose of administered vaccine. * Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period after each administered vaccine. * Occurrence of overall adverse events and serious adverse events during the entire period of study.
Time frame: 1 year from the start of study enrolment
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Comparison of each dose of vaccine