A Study to Evaluate the Safety and Immunogenicity of H7N9 Influenza Vaccine (AT-501) in Healthy Adult Subjects

NCT02436928 Phase 1/Phase 2 COMPLETED

This study aims to evaluate the safety and immunogenicity of an inactivated cell culture derived H7N9 vaccine in healthy adult subjects.

Details

Lead sponsor	Medigen Vaccine Biologics Corp.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	200
Start date	2015-04
Completion	2016-02

Conditions

• H7N9 Influenza Vaccine

Interventions

• AT-501 High Dose vaccine
• AT-501 High Dose vaccine with Adjuvant
• AT-501 Low Dose vaccine
• AT-501 Low Dose vaccine with Adjuvant

Primary outcomes

• Safety of AT-501 vaccine measured by Adverse Event — 1 year from the start of study enrolment
  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.
• Immunogenicity of AT-501 vaccine measured by HI titers — 1 year from the start of study enrolment
  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

Countries

Taiwan