NCT03718468

A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine

A Phase III, Prospective, Randomized, Open-Labeled, Active-Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine, GC FLU, in Adults Aged 20 to 50

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 842 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to demonstrate the immunogenic efficacy of GC FLU Quadrivalent Pre-filled Syringe inj. (GC FLU), a quadrivalent influenza virus vaccine, is non-inferior to the active control, Fluarix Tetra. This study is designed to be a randomized, open-labelled, active-controlled, parallel, phase III study recruiting subjects from multiple study sites. Approximately 840 eligible subjects are planned to enroll in order to obtain 800 evaluable (= per-protocol) subjects. Subjects will be randomized and assigned to GC FLU or Fluarix Tetra (active control, AC) group in 1:1 ratio.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	GC FLU Quadrivalent	A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.
BIOLOGICAL	Fluarix Tetra	A single dose administration of Fluarix Tetra will be through intramuscular injection.

Timeline

• Start date: 2018-10-30
• Primary completion: 2019-07-03
• Completion: 2019-07-03
• First posted: 2018-10-24
• Last updated: 2019-08-14

Locations

4 sites across 1 country: Taiwan